Active Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus
Conditions
Keywords
CLE, SLE, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus
Brief summary
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).
Interventions
Administered as specified in the treatment arm.
DRUGPlacebo
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Part A: 1. Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement. 2. At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist. 3. Demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization. Part B: 1\. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations. Key
Exclusion criteria
1. Active lupus nephritis or moderate-to-severe or chronic kidney disease. 2. Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus). 3. History of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening. 4. Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to Randomization. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 | Baseline to Week 24 | An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week. |
| Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 | Baseline to Week 16 | The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Baseline, Week 12, 16 and 24 | The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. |
| Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 | Baseline, Week 12 | The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. |
| Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | Week 24 | The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=4-point reduction from baseline in CLASI-A score are reported here. |
| Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12, Week 16 | The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=4-point reduction from baseline in CLASI-A score are reported here. |
| Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | Week 24 | The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=7-point reduction from baseline in CLASI-A score are reported here. |
| Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12, Week 16 | The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=7-point reduction from baseline in CLASI-A score are reported here. |
| Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24 | Week 24 | An SRI-4 at Week 24 was a categorical response variable (Yes/No) incorporating the following criteria for achievement of responder status (i.e., all criteria must have been met to achieve responder status): A reduction from baseline of ≥4 points in SLEDAI-2K, No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B, No worsening from baseline in participant's lupus disease activity, defined by a \<1-point increase in the PGA (VAS) \[on a scale of 0 to 10\],No changes to protocol-specified medication rules,as follows (all criteria were required to be met): No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy; Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24. The percentage of participants who had responded to each of the 4 criteria was also reported. |
| Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 | Baseline to Week 24 | The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores representing increased disease activity. |
| Part A: Percentage of Participants With no New Organ System Affected at Week 24 | Week 24 | No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity. |
| Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24 | Baseline to Week 24 | The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participants current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity. |
| Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 36 | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect. |
| Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 28 | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect. |
| Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Baseline up to Week 36 | — |
| Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Baseline up to Week 28 | — |
| Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to Week 36 | — |
| Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to Week 28 | — |
| Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24 | Week 24 | CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. |
| Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | Baseline up to Week 36 | — |
| Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | Baseline up to Week 28 | — |
| Part A: Number of Participants With Positive BIIB059 Antibodies | Baseline up to Week 24 | — |
| Part B: Number of Participants With Positive BIIB059 Antibodies | Baseline up to Week 16 | — |
| Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Baseline up to Week 24 | — |
| Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Baseline up to Week 16 | — |
| Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Baseline to Week 24 | Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody. |
| Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Baseline to Week 12 | Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody. |
| Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | Baseline to Week 12 | Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed. |
| Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | Baseline up to Week 24 | — |
| Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Baseline up to Week 16 | — |
| Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Baseline to Week 24 | Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody |
| Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Baseline to Week 12 | Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody. |
| Part A: Serum Concentration of BIIB059 | Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253 | — |
| Part B: Serum Concentration of BIIB059 | Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197 | — |
| Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Baseline to Week 24 | Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL). |
| Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 12, Week 16 | CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. |
Countries
Argentina, Bulgaria, Colombia, Israel, Mexico, Philippines, Poland, Serbia, South Korea, Taiwan, Thailand, United States
Participant flow
Recruitment details
Participants were enrolled at 129 investigative sites in Argentina, Bulgaria, Colombia, Israel, Korea, Mexico, Philippines, Poland, Serbia, Taiwan, Thailand, and the United States from October 20, 2016 to November 18, 2019.
Pre-assignment details
A total of 264 participants were enrolled in the study. The study had two parts, Part A (participants with Systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement) and Part B (participants with active cutaneous lupus erythematosus (CLE), including discoid lupus erythematosus (DLE), with or without SLE).
Participants by arm
| Arm | Count |
|---|---|
| Part A: Placebo Participants with systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20. | 56 |
| Part A: BIIB059 50 mg Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20. | 6 |
| Part A: BIIB059 150 mg Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20. | 6 |
| Part A: BIIB059 450 mg Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20. | 64 |
| Part B: Placebo Participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12. | 33 |
| Part B: BIIB059 50 mg Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12. | 26 |
| Part B: BIIB059 150 mg Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12. | 25 |
| Part B: BIIB059 450 mg Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12. | 48 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Consent withdrawn | 2 | 0 | 0 | 4 | 3 | 2 | 1 | 3 |
| Overall Study | Death | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Part A: Placebo | Part A: BIIB059 50 mg | Part A: BIIB059 150 mg | Part A: BIIB059 450 mg | Part B: Placebo | Part B: BIIB059 50 mg | Part B: BIIB059 150 mg | Part B: BIIB059 450 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 12.2 | 35.0 years STANDARD_DEVIATION 14.4 | 40.8 years STANDARD_DEVIATION 13.4 | 40.3 years STANDARD_DEVIATION 11.4 | 43.4 years STANDARD_DEVIATION 11.6 | 43.3 years STANDARD_DEVIATION 15.3 | 43.6 years STANDARD_DEVIATION 12.1 | 44.0 years STANDARD_DEVIATION 12.6 | 42.1 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 1 Participants | 2 Participants | 24 Participants | 3 Participants | 5 Participants | 1 Participants | 4 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 4 Participants | 3 Participants | 20 Participants | 22 Participants | 14 Participants | 13 Participants | 34 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 1 Participants | 1 Participants | 20 Participants | 8 Participants | 7 Participants | 11 Participants | 10 Participants | 73 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 4 Participants | 2 Participants | 12 Participants | 14 Participants | 7 Participants | 6 Participants | 17 Participants | 75 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 2 Participants | 5 Participants | 2 Participants | 5 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 1 Participants | 3 Participants | 24 Participants | 8 Participants | 10 Participants | 11 Participants | 13 Participants | 89 Participants |
| Race (NIH/OMB) White | 16 Participants | 1 Participants | 1 Participants | 17 Participants | 9 Participants | 4 Participants | 6 Participants | 13 Participants | 67 Participants |
| Sex: Female, Male Female | 49 Participants | 6 Participants | 5 Participants | 63 Participants | 30 Participants | 20 Participants | 20 Participants | 36 Participants | 229 Participants |
| Sex: Female, Male Male | 7 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 6 Participants | 5 Participants | 12 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 56 | 0 / 6 | 0 / 6 | 0 / 64 | 0 / 33 | 0 / 26 | 0 / 25 | 0 / 48 |
| other Total, other adverse events | 22 / 56 | 3 / 6 | 6 / 6 | 22 / 64 | 19 / 33 | 16 / 26 | 10 / 25 | 28 / 48 |
| serious Total, serious adverse events | 6 / 56 | 0 / 6 | 1 / 6 | 3 / 64 | 3 / 33 | 1 / 26 | 3 / 25 | 3 / 48 |
Outcome results
Primary
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24
An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
Time frame: Baseline to Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 | -12.7 joints | Standard Deviation 10.3 |
| Part A: BIIB059 50 mg | Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 | -9.0 joints | Standard Deviation 5.7 |
| Part A: BIIB059 150 mg | Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 | -13.0 joints | — |
| Part A: BIIB059 450 mg | Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 | -14.5 joints | Standard Deviation 8.7 |
Comparison: A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.p-value: 0.03795% CI: [-6.7, -0.2]MMRM
Primary
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Time frame: Baseline to Week 16
Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 | -15.03 percent change | Standard Deviation 37.23 |
| Part A: BIIB059 50 mg | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 | -35.52 percent change | Standard Deviation 33.35 |
| Part A: BIIB059 150 mg | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 | -47.11 percent change | Standard Deviation 34.1 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 | -41.66 percent change | Standard Deviation 37.33 |
Comparison: A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.p-value: 0.01595% CI: [-43.7, -4.88]MMRM
Comparison: A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.p-value: <0.00195% CI: [-52.71, -14.12]MMRM
Comparison: A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.p-value: 0.00195% CI: [-44.55, -11.42]MMRM
Secondary
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24
Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL).
Time frame: Baseline to Week 24
Population: Safety population included all randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, overall number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Baseline | 2.46 IU/mL | Standard Deviation 2.532 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Change at Week 24 | -0.07 IU/mL | Standard Deviation 1.975 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Baseline | 0.33 IU/mL | Standard Deviation 0.511 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | -0.06 IU/mL | Standard Deviation 0.266 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Change at Week 24 | 0.07 IU/mL | Standard Deviation 0.437 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Baseline | 0.10 IU/mL | Standard Deviation 0.089 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | -0.03 IU/mL | Standard Deviation 0.082 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Baseline | 1.73 IU/mL | Standard Deviation 1.66 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Baseline | 0.17 IU/mL | Standard Deviation 0.163 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Change at Week 24 | 1.07 IU/mL | Standard Deviation 2.89 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | 0.07 IU/mL | Standard Deviation 0.163 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Baseline | 2.52 IU/mL | Standard Deviation 2.219 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | -0.07 IU/mL | Standard Deviation 0.34 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Change at Week 24 | -0.70 IU/mL | Standard Deviation 2.398 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | C. tetani IgG Antibody: Baseline | 3.30 IU/mL | Standard Deviation 3.674 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24 | Diphtheria IgG Antibody: Baseline | 0.33 IU/mL | Standard Deviation 0.444 |
Secondary
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.
Time frame: Baseline to Week 24
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, overall number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Baseline | 0.852 milligrams per liter (mg/L) | Standard Deviation 2.5002 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Change at Week 24 | 0.241 milligrams per liter (mg/L) | Standard Deviation 1.1929 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Baseline | 6.4300 milligrams per liter (mg/L) | Standard Deviation 10.99806 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Change at Week 24 | 0.445 milligrams per liter (mg/L) | Standard Deviation 1.9595 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Baseline | 1.768 milligrams per liter (mg/L) | Standard Deviation 1.9872 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Change at Week 24 | 0.502 milligrams per liter (mg/L) | Standard Deviation 7.1412 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Change at Week 24 | -1.0336 milligrams per liter (mg/L) | Standard Deviation 5.35192 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Change at Week 24 | 0.0455 milligrams per liter (mg/L) | Standard Deviation 4.96426 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Baseline | 6.443 milligrams per liter (mg/L) | Standard Deviation 5.8006 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Change at Week 24 | 0.3963 milligrams per liter (mg/L) | Standard Deviation 1.70256 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Baseline | 3.1978 milligrams per liter (mg/L) | Standard Deviation 7.08938 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Baseline | 5.4506 milligrams per liter (mg/L) | Standard Deviation 6.82628 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Baseline | 1.0274 milligrams per liter (mg/L) | Standard Deviation 1.44706 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Change at Week 24 | 0.217 milligrams per liter (mg/L) | Standard Deviation 1.7957 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Change at Week 24 | 0.0925 milligrams per liter (mg/L) | Standard Deviation 1.107 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Baseline | 1.2607 milligrams per liter (mg/L) | Standard Deviation 1.77918 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Baseline | 1.781 milligrams per liter (mg/L) | Standard Deviation 2.9291 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Change at Week 24 | -0.392 milligrams per liter (mg/L) | Standard Deviation 1.7998 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Change at Week 24 | 0.651 milligrams per liter (mg/L) | Standard Deviation 3.5642 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Baseline | 4.203 milligrams per liter (mg/L) | Standard Deviation 6.4231 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Change at Week 24 | -0.0886 milligrams per liter (mg/L) | Standard Deviation 0.7589 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Change at Week 24 | 0.078 milligrams per liter (mg/L) | Standard Deviation 1.0468 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Change at Week 24 | 2.2418 milligrams per liter (mg/L) | Standard Deviation 6.97357 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Baseline | 2.017 milligrams per liter (mg/L) | Standard Deviation 4.9787 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Baseline | 0.734 milligrams per liter (mg/L) | Standard Deviation 1.2954 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Baseline | 1.401 milligrams per liter (mg/L) | Standard Deviation 2.0138 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Baseline | 15.2372 milligrams per liter (mg/L) | Standard Deviation 11.46102 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Change at Week 24 | -0.096 milligrams per liter (mg/L) | Standard Deviation 2.8194 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Change at Week 24 | -0.025 milligrams per liter (mg/L) | Standard Deviation 0.5104 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Baseline | 1.562 milligrams per liter (mg/L) | Standard Deviation 2.4661 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Baseline | 3.229 milligrams per liter (mg/L) | Standard Deviation 4.8212 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Change at Week 24 | 0.427 milligrams per liter (mg/L) | Standard Deviation 4.6695 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Baseline | 4.921 milligrams per liter (mg/L) | Standard Deviation 4.2218 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Baseline | 2.610 milligrams per liter (mg/L) | Standard Deviation 4.4802 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Baseline | 4.817 milligrams per liter (mg/L) | Standard Deviation 5.7702 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Change at Week 24 | 0.603 milligrams per liter (mg/L) | Standard Deviation 5.1284 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Change at Week 24 | 0.813 milligrams per liter (mg/L) | Standard Deviation 3.9116 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Change at Week 24 | 0.244 milligrams per liter (mg/L) | Standard Deviation 1.8324 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Baseline | 3.926 milligrams per liter (mg/L) | Standard Deviation 5.7931 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Change at Week 24 | -0.635 milligrams per liter (mg/L) | Standard Deviation 6.6892 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Baseline | 3.348 milligrams per liter (mg/L) | Standard Deviation 6.494 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Baseline | 1.563 milligrams per liter (mg/L) | Standard Deviation 2.0162 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Baseline | 7.910 milligrams per liter (mg/L) | Standard Deviation 11.3177 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Change at Week 24 | 0.060 milligrams per liter (mg/L) | Standard Deviation 0.8496 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Change at Week 24 | -0.448 milligrams per liter (mg/L) | Standard Deviation 2.4975 |
| Part A: Placebo | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Change at Week 24 | 0.014 milligrams per liter (mg/L) | Standard Deviation 0.8316 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Baseline | 35.2000 milligrams per liter (mg/L) | Standard Deviation 58.79083 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Baseline | 3.873 milligrams per liter (mg/L) | Standard Deviation 3.84 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Change at Week 24 | 0.055 milligrams per liter (mg/L) | Standard Deviation 2.984 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Baseline | 5.715 milligrams per liter (mg/L) | Standard Deviation 6.9239 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Change at Week 24 | -1.648 milligrams per liter (mg/L) | Standard Deviation 7.179 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Baseline | 2.1450 milligrams per liter (mg/L) | Standard Deviation 2.39861 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Change at Week 24 | -0.2017 milligrams per liter (mg/L) | Standard Deviation 2.43817 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Baseline | 2.602 milligrams per liter (mg/L) | Standard Deviation 4.4908 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Change at Week 24 | -1.510 milligrams per liter (mg/L) | Standard Deviation 4.9524 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Baseline | 10.693 milligrams per liter (mg/L) | Standard Deviation 17.4616 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Change at Week 24 | -4.692 milligrams per liter (mg/L) | Standard Deviation 19.3477 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Baseline | 4.462 milligrams per liter (mg/L) | Standard Deviation 4.1178 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Change at Week 24 | -2.168 milligrams per liter (mg/L) | Standard Deviation 5.1775 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Baseline | 8.5333 milligrams per liter (mg/L) | Standard Deviation 7.97928 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Change at Week 24 | -1.3283 milligrams per liter (mg/L) | Standard Deviation 7.23188 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Baseline | 3.1933 milligrams per liter (mg/L) | Standard Deviation 3.01698 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Change at Week 24 | -1.3300 milligrams per liter (mg/L) | Standard Deviation 3.85666 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Baseline | 2.710 milligrams per liter (mg/L) | Standard Deviation 3.7028 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Change at Week 24 | -1.327 milligrams per liter (mg/L) | Standard Deviation 3.8703 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Baseline | 1.8300 milligrams per liter (mg/L) | Standard Deviation 3.00647 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Change at Week 24 | -0.0767 milligrams per liter (mg/L) | Standard Deviation 0.64252 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Baseline | 17.847 milligrams per liter (mg/L) | Standard Deviation 32.716 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Change at Week 24 | -8.062 milligrams per liter (mg/L) | Standard Deviation 36.3708 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Baseline | 3.203 milligrams per liter (mg/L) | Standard Deviation 3.628 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Change at Week 24 | -1.615 milligrams per liter (mg/L) | Standard Deviation 4.5191 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Baseline | 2.355 milligrams per liter (mg/L) | Standard Deviation 3.5388 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Change at Week 24 | -1.648 milligrams per liter (mg/L) | Standard Deviation 3.7849 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Baseline | 13.982 milligrams per liter (mg/L) | Standard Deviation 16.1988 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Change at Week 24 | -7.027 milligrams per liter (mg/L) | Standard Deviation 19.5245 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Baseline | 6.287 milligrams per liter (mg/L) | Standard Deviation 7.4576 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Change at Week 24 | -2.262 milligrams per liter (mg/L) | Standard Deviation 9.1738 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Baseline | 11.422 milligrams per liter (mg/L) | Standard Deviation 16.0156 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Change at Week 24 | -6.123 milligrams per liter (mg/L) | Standard Deviation 17.3744 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Baseline | 3.475 milligrams per liter (mg/L) | Standard Deviation 2.246 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Change at Week 24 | -1.172 milligrams per liter (mg/L) | Standard Deviation 2.2061 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Change at Week 24 | -18.0750 milligrams per liter (mg/L) | Standard Deviation 61.75995 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Baseline | 10.857 milligrams per liter (mg/L) | Standard Deviation 14.6665 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Change at Week 24 | -6.447 milligrams per liter (mg/L) | Standard Deviation 16.0973 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Baseline | 26.7958 milligrams per liter (mg/L) | Standard Deviation 45.54328 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Change at Week 24 | -21.4475 milligrams per liter (mg/L) | Standard Deviation 46.04992 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Baseline | 5.743 milligrams per liter (mg/L) | Standard Deviation 10.5586 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Change at Week 24 | -4.000 milligrams per liter (mg/L) | Standard Deviation 11.171 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Baseline | 1.897 milligrams per liter (mg/L) | Standard Deviation 1.308 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Change at Week 24 | -0.150 milligrams per liter (mg/L) | Standard Deviation 1.3425 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Baseline | 6.600 milligrams per liter (mg/L) | Standard Deviation 12.2931 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Change at Week 24 | -5.042 milligrams per liter (mg/L) | Standard Deviation 12.7997 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Baseline | 50.3175 milligrams per liter (mg/L) | Standard Deviation 56.06189 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Change at Week 24 | -0.782 milligrams per liter (mg/L) | Standard Deviation 5.3918 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Change at Week 24 | -0.2067 milligrams per liter (mg/L) | Standard Deviation 1.3937 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Baseline | 4.458 milligrams per liter (mg/L) | Standard Deviation 6.1968 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Change at Week 24 | -29.3558 milligrams per liter (mg/L) | Standard Deviation 44.83082 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Baseline | 2.077 milligrams per liter (mg/L) | Standard Deviation 2.0373 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Change at Week 24 | -1.607 milligrams per liter (mg/L) | Standard Deviation 4.1148 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Change at Week 24 | 0.190 milligrams per liter (mg/L) | Standard Deviation 0.4725 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Baseline | 8.353 milligrams per liter (mg/L) | Standard Deviation 8.4621 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Baseline | 8.167 milligrams per liter (mg/L) | Standard Deviation 9.5488 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Baseline | 1.2733 milligrams per liter (mg/L) | Standard Deviation 0.9679 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Baseline | 13.507 milligrams per liter (mg/L) | Standard Deviation 17.7231 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Change at Week 24 | -3.673 milligrams per liter (mg/L) | Standard Deviation 8.5727 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Baseline | 2.705 milligrams per liter (mg/L) | Standard Deviation 5.3558 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Baseline | 11.952 milligrams per liter (mg/L) | Standard Deviation 10.2915 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Baseline | 5.525 milligrams per liter (mg/L) | Standard Deviation 6.4123 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Baseline | 21.8742 milligrams per liter (mg/L) | Standard Deviation 22.32961 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Change at Week 24 | -3.083 milligrams per liter (mg/L) | Standard Deviation 5.3923 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Change at Week 24 | -1.5483 milligrams per liter (mg/L) | Standard Deviation 3.27227 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Baseline | 0.685 milligrams per liter (mg/L) | Standard Deviation 0.3293 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Baseline | 2.810 milligrams per liter (mg/L) | Standard Deviation 4.4518 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Change at Week 24 | -5.898 milligrams per liter (mg/L) | Standard Deviation 9.5001 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Change at Week 24 | -3.657 milligrams per liter (mg/L) | Standard Deviation 6.6997 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Change at Week 24 | -1.975 milligrams per liter (mg/L) | Standard Deviation 3.25 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Change at Week 24 | -0.907 milligrams per liter (mg/L) | Standard Deviation 2.8144 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Change at Week 24 | -0.795 milligrams per liter (mg/L) | Standard Deviation 1.6009 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Baseline | 2.6183 milligrams per liter (mg/L) | Standard Deviation 3.2121 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Change at Week 24 | -3.740 milligrams per liter (mg/L) | Standard Deviation 4.4122 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Baseline | 1.5900 milligrams per liter (mg/L) | Standard Deviation 1.79117 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Change at Week 24 | -0.798 milligrams per liter (mg/L) | Standard Deviation 7.1605 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Baseline | 2.980 milligrams per liter (mg/L) | Standard Deviation 1.8997 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Change at Week 24 | -13.0942 milligrams per liter (mg/L) | Standard Deviation 16.16771 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Change at Week 24 | -0.5750 milligrams per liter (mg/L) | Standard Deviation 1.02039 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Baseline | 4.202 milligrams per liter (mg/L) | Standard Deviation 4.8105 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Change at Week 24 | -2.8917 milligrams per liter (mg/L) | Standard Deviation 5.30027 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Change at Week 24 | -7.322 milligrams per liter (mg/L) | Standard Deviation 16.4934 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Baseline | 14.040 milligrams per liter (mg/L) | Standard Deviation 14.0133 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Change at Week 24 | -0.565 milligrams per liter (mg/L) | Standard Deviation 1.4395 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Change at Week 24 | -0.915 milligrams per liter (mg/L) | Standard Deviation 1.0038 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Change at Week 24 | -1.220 milligrams per liter (mg/L) | Standard Deviation 1.7397 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Change at Week 24 | 0.100 milligrams per liter (mg/L) | Standard Deviation 9.5476 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Baseline | 1.317 milligrams per liter (mg/L) | Standard Deviation 1.5754 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Baseline | 7.0033 milligrams per liter (mg/L) | Standard Deviation 8.53321 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Baseline | 5.630 milligrams per liter (mg/L) | Standard Deviation 5.3371 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Baseline | 4.095 milligrams per liter (mg/L) | Standard Deviation 4.7768 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Baseline | 4.332 milligrams per liter (mg/L) | Standard Deviation 4.0216 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Change at Week 24 | 0.125 milligrams per liter (mg/L) | Standard Deviation 1.8192 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Change at Week 24 | -0.276 milligrams per liter (mg/L) | Standard Deviation 1.6589 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Baseline | 1.138 milligrams per liter (mg/L) | Standard Deviation 1.6187 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Baseline | 0.262 milligrams per liter (mg/L) | Standard Deviation 0.3381 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Baseline | 1.957 milligrams per liter (mg/L) | Standard Deviation 2.7845 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 12F IgG AB: Change at Week 24 | -0.072 milligrams per liter (mg/L) | Standard Deviation 0.1772 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Baseline | 1.800 milligrams per liter (mg/L) | Standard Deviation 2.2552 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Baseline | 5.183 milligrams per liter (mg/L) | Standard Deviation 6.5611 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Change at Week 24 | 0.329 milligrams per liter (mg/L) | Standard Deviation 2.339 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 14 IgG AB: Change at Week 24 | 0.597 milligrams per liter (mg/L) | Standard Deviation 3.6401 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 22F IgG AB: Change at Week 24 | 0.087 milligrams per liter (mg/L) | Standard Deviation 0.935 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Baseline | 3.690 milligrams per liter (mg/L) | Standard Deviation 5.3754 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 5 IgG AB: Baseline | 4.442 milligrams per liter (mg/L) | Standard Deviation 3.9255 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Change at Week 24 | 0.475 milligrams per liter (mg/L) | Standard Deviation 3.5101 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 15B IgG AB: Change at Week 24 | -0.341 milligrams per liter (mg/L) | Standard Deviation 2.2893 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Baseline | 4.277 milligrams per liter (mg/L) | Standard Deviation 4.8458 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Change at Week 24 | 0.060 milligrams per liter (mg/L) | Standard Deviation 0.6525 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 17F IgG AB: Change at Week 24 | 1.330 milligrams per liter (mg/L) | Standard Deviation 4.8122 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 23F IgG AB: Baseline | 1.797 milligrams per liter (mg/L) | Standard Deviation 2.7461 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Baseline | 2.485 milligrams per liter (mg/L) | Standard Deviation 3.8363 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 4 IgG AB: Baseline | 0.429 milligrams per liter (mg/L) | Standard Deviation 0.5696 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 18C IgG AB: Change at Week 24 | 0.054 milligrams per liter (mg/L) | Standard Deviation 2.2468 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Change at Week 24 | 0.8122 milligrams per liter (mg/L) | Standard Deviation 3.6209 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Baseline | 14.9554 milligrams per liter (mg/L) | Standard Deviation 11.40262 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 33F IgG AB: Change at Week 24 | 0.066 milligrams per liter (mg/L) | Standard Deviation 1.138 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19A IgG AB: Change at Week 24 | 4.0988 milligrams per liter (mg/L) | Standard Deviation 9.00464 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 3 IgG AB: Baseline | 1.6579 milligrams per liter (mg/L) | Standard Deviation 3.35454 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Baseline | 2.609 milligrams per liter (mg/L) | Standard Deviation 3.1856 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 6 IgG AB: Change at Week 24 | 0.070 milligrams per liter (mg/L) | Standard Deviation 2.4772 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 19F IgG AB: Change at Week 24 | 1.136 milligrams per liter (mg/L) | Standard Deviation 3.2837 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Change at Week 24 | -0.011 milligrams per liter (mg/L) | Standard Deviation 1.2676 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 1 IgG AB: Baseline | 1.495 milligrams per liter (mg/L) | Standard Deviation 3.3589 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Change at Week 24 | 0.1281 milligrams per liter (mg/L) | Standard Deviation 0.84548 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Baseline | 4.0902 milligrams per liter (mg/L) | Standard Deviation 4.01659 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Baseline | 2.337 milligrams per liter (mg/L) | Standard Deviation 4.6658 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 8 IgG AB: Baseline | 1.5890 milligrams per liter (mg/L) | Standard Deviation 4.46616 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9N IgG AB: Change at Week 24 | 0.499 milligrams per liter (mg/L) | Standard Deviation 4.0782 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Baseline | 2.2696 milligrams per liter (mg/L) | Standard Deviation 4.71508 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Change at Week 24 | 0.3053 milligrams per liter (mg/L) | Standard Deviation 3.13517 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 9V IgG AB: Change at Week 24 | 0.6701 milligrams per liter (mg/L) | Standard Deviation 4.703 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 20 IgG AB: Change at Week 24 | 1.2437 milligrams per liter (mg/L) | Standard Deviation 2.42526 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Baseline | 7.631 milligrams per liter (mg/L) | Standard Deviation 8.2417 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 7 IgG AB: Baseline | 3.0983 milligrams per liter (mg/L) | Standard Deviation 6.90958 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 2 IgG AB: Baseline | 1.626 milligrams per liter (mg/L) | Standard Deviation 2.6861 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 10A IgG AB: Change at Week 24 | -0.384 milligrams per liter (mg/L) | Standard Deviation 5.8464 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24 | Sero 11A IgG AB: Baseline | 2.308 milligrams per liter (mg/L) | Standard Deviation 3.0647 |
Secondary
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels
Time frame: Baseline up to Week 24
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin M (IgM): Baseline | 1.046 grams per Liter (g/L) | Standard Deviation 0.657 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | 0.004 grams per Liter (g/L) | Standard Deviation 0.137 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | -0.003 grams per Liter (g/L) | Standard Deviation 0.191 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin A (IgA): Baseline | 3.350 grams per Liter (g/L) | Standard Deviation 1.862 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin G (IgG): Baseline | 14.423 grams per Liter (g/L) | Standard Deviation 4.927 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | 0.033 grams per Liter (g/L) | Standard Deviation 0.529 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | 1.057 grams per Liter (g/L) | Standard Deviation 2.832 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | 0.874 grams per Liter (g/L) | Standard Deviation 3.376 |
| Part A: Placebo | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | -0.093 grams per Liter (g/L) | Standard Deviation 0.704 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin A (IgA): Baseline | 3.610 grams per Liter (g/L) | Standard Deviation 0.73 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin M (IgM): Baseline | 1.065 grams per Liter (g/L) | Standard Deviation 0.507 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin G (IgG): Baseline | 15.723 grams per Liter (g/L) | Standard Deviation 1.584 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | -0.433 grams per Liter (g/L) | Standard Deviation 1.188 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | -0.468 grams per Liter (g/L) | Standard Deviation 1.333 |
| Part A: BIIB059 50 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | -0.050 grams per Liter (g/L) | Standard Deviation 0.113 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | -0.150 grams per Liter (g/L) | Standard Deviation 0.16 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | -0.057 grams per Liter (g/L) | Standard Deviation 0.966 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | -0.790 grams per Liter (g/L) | Standard Deviation 4.967 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin G (IgG): Baseline | 17.620 grams per Liter (g/L) | Standard Deviation 5.502 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin M (IgM): Baseline | 1.242 grams per Liter (g/L) | Standard Deviation 0.718 |
| Part A: BIIB059 150 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin A (IgA): Baseline | 4.080 grams per Liter (g/L) | Standard Deviation 1.537 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | -0.072 grams per Liter (g/L) | Standard Deviation 0.409 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin A (IgA): Baseline | 3.116 grams per Liter (g/L) | Standard Deviation 1.682 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | -0.006 grams per Liter (g/L) | Standard Deviation 0.305 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | 0.012 grams per Liter (g/L) | Standard Deviation 0.505 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin G (IgG): Baseline | 14.792 grams per Liter (g/L) | Standard Deviation 6.778 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | 0.233 grams per Liter (g/L) | Standard Deviation 2.478 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | 0.758 grams per Liter (g/L) | Standard Deviation 2.599 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | Immunoglobulin M (IgM): Baseline | 1.106 grams per Liter (g/L) | Standard Deviation 0.953 |
| Part A: BIIB059 450 mg | Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | -0.065 grams per Liter (g/L) | Standard Deviation 0.294 |
Secondary
Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24
The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participants current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity.
Time frame: Baseline to Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24 | -2.46 score on a scale | Standard Deviation 2.13 |
| Part A: BIIB059 50 mg | Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24 | -2.05 score on a scale | Standard Deviation 1.18 |
| Part A: BIIB059 150 mg | Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24 | -0.12 score on a scale | Standard Deviation 1.48 |
| Part A: BIIB059 450 mg | Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24 | -2.45 score on a scale | Standard Deviation 2.33 |
Comparison: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.p-value: 0.66795% CI: [-0.9, 0.58]MMRM
Secondary
Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24
The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores representing increased disease activity.
Time frame: Baseline to Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 | -2.1 score on a scale | Standard Deviation 3.3 |
| Part A: BIIB059 50 mg | Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 | -3.0 score on a scale | Standard Deviation 4.7 |
| Part A: BIIB059 150 mg | Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 | -1.3 score on a scale | Standard Deviation 2.4 |
| Part A: BIIB059 450 mg | Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 | -4.4 score on a scale | Standard Deviation 4.2 |
Comparison: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.p-value: 0.00795% CI: [-3, -0.5]MMRM
Secondary
Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
Time frame: Baseline up to Week 36
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
| Part A: BIIB059 50 mg | Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
| Part A: BIIB059 150 mg | Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
| Part A: BIIB059 450 mg | Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
Secondary
Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Baseline up to Week 36
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
| Part A: BIIB059 50 mg | Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
| Part A: BIIB059 150 mg | Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
| Part A: BIIB059 450 mg | Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
Secondary
Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Baseline up to Week 36
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
| Part A: BIIB059 50 mg | Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
| Part A: BIIB059 150 mg | Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
| Part A: BIIB059 450 mg | Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
Secondary
Part A: Number of Participants With Positive BIIB059 Antibodies
Time frame: Baseline up to Week 24
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Positive BIIB059 Antibodies | 1 Participants |
| Part A: BIIB059 50 mg | Part A: Number of Participants With Positive BIIB059 Antibodies | 0 Participants |
| Part A: BIIB059 150 mg | Part A: Number of Participants With Positive BIIB059 Antibodies | 0 Participants |
| Part A: BIIB059 450 mg | Part A: Number of Participants With Positive BIIB059 Antibodies | 5 Participants |
Secondary
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Time frame: Baseline up to Week 36
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 38 Participants |
| Part A: Placebo | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 6 Participants |
| Part A: BIIB059 50 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part A: BIIB059 50 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 Participants |
| Part A: BIIB059 150 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Part A: BIIB059 150 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Part A: BIIB059 450 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 36 Participants |
| Part A: BIIB059 450 mg | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
Secondary
Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24
An SRI-4 at Week 24 was a categorical response variable (Yes/No) incorporating the following criteria for achievement of responder status (i.e., all criteria must have been met to achieve responder status): A reduction from baseline of ≥4 points in SLEDAI-2K, No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B, No worsening from baseline in participant's lupus disease activity, defined by a \<1-point increase in the PGA (VAS) \[on a scale of 0 to 10\],No changes to protocol-specified medication rules,as follows (all criteria were required to be met): No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy; Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24. The percentage of participants who had responded to each of the 4 criteria was also reported.
Time frame: Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24 | 28.57 percentage of participants |
| Part A: BIIB059 50 mg | Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24 | 33.33 percentage of participants |
| Part A: BIIB059 150 mg | Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24 | 16.67 percentage of participants |
| Part A: BIIB059 450 mg | Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24 | 56.25 percentage of participants |
Secondary
Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=4-point reduction from baseline in CLASI-A score are reported here.
Time frame: Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 57.89 percentage of participants |
| Part A: BIIB059 50 mg | Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 83.66 percentage of participants |
| Part A: BIIB059 150 mg | Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 16.67 percentage of participants |
| Part A: BIIB059 450 mg | Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 71.79 percentage of participants |
Secondary
Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=7-point reduction from baseline in CLASI-A score are reported here.
Time frame: Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 34.21 percentage of participants |
| Part A: BIIB059 50 mg | Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 66.67 percentage of participants |
| Part A: BIIB059 150 mg | Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 16.67 percentage of participants |
| Part A: BIIB059 450 mg | Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | 56.41 percentage of participants |
Secondary
Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Time frame: Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies those with baseline CLASI-A \>=8 following protocol amendment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24 | 42.11 percentage of participants |
| Part A: BIIB059 50 mg | Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24 | 50 percentage of participants |
| Part A: BIIB059 150 mg | Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24 | 16.67 percentage of participants |
| Part A: BIIB059 450 mg | Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24 | 64.10 percentage of participants |
Secondary
Part A: Percentage of Participants With no New Organ System Affected at Week 24
No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
Time frame: Week 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: Placebo | Part A: Percentage of Participants With no New Organ System Affected at Week 24 | 82.14 percentage of participants |
| Part A: BIIB059 50 mg | Part A: Percentage of Participants With no New Organ System Affected at Week 24 | 100.00 percentage of participants |
| Part A: BIIB059 150 mg | Part A: Percentage of Participants With no New Organ System Affected at Week 24 | 50.00 percentage of participants |
| Part A: BIIB059 450 mg | Part A: Percentage of Participants With no New Organ System Affected at Week 24 | 85.94 percentage of participants |
Secondary
Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Time frame: Baseline, Week 12, 16 and 24
Population: MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 12 | -36.63 percent change | Standard Deviation 28.23 |
| Part A: Placebo | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 24 | -45.40 percent change | Standard Deviation 34.38 |
| Part A: Placebo | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 16 | -42.55 percent change | Standard Deviation 32.46 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 12 | -29.32 percent change | Standard Deviation 14.66 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 24 | -58.61 percent change | Standard Deviation 35.16 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 16 | -41.76 percent change | Standard Deviation 19.72 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 16 | -6.19 percent change | Standard Deviation 21.31 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 12 | -8.39 percent change | Standard Deviation 34.48 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 24 | -17.92 percent change | Standard Deviation 31.16 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 12 | -44.36 percent change | Standard Deviation 39.69 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 24 | -60.59 percent change | Standard Deviation 37.36 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Change at Week 16 | -50.20 percent change | Standard Deviation 38.32 |
Comparison: Week 12: A MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.p-value: 0.2295% CI: [-25.94, 6.08]MMRM
Comparison: Week 16: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.p-value: 0.29395% CI: [-25.82, 7.9]MMRM
Comparison: Week 24: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.p-value: 0.06295% CI: [-32.28, 0.79]MMRM
Secondary
Part A: Percent Change From Baseline in Vaccine Titers at Week 24
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody
Time frame: Baseline to Week 24
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, overall number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 1 IgG AB: Change at Week 24 | 53.629 percent change | Standard Deviation 206.5979 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | 15.310 percent change | Standard Deviation 141.4934 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 15B IgG AB: Change at Week 24 | 11.206 percent change | Standard Deviation 116.7649 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 8 IgG AB: Change at Week 24 | 13.540 percent change | Standard Deviation 64.9487 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 18C IgG AB: Change at Week 24 | 14.720 percent change | Standard Deviation 64.9702 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 3 IgG AB: Change at Week 24 | -10.854 percent change | Standard Deviation 34.9399 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 23F IgG AB: Change at Week 24 | 0.215 percent change | Standard Deviation 50.6348 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9N IgG AB: Change at Week 24 | 13.302 percent change | Standard Deviation 108.1678 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19A IgG AB: Change at Week 24 | 21.433 percent change | Standard Deviation 55.0044 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 5 IgG AB: Change at Week 24 | 13.293 percent change | Standard Deviation 54.1115 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 14 IgG AB: Change at Week 24 | -3.087 percent change | Standard Deviation 55.1562 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9V IgG AB: Change at Week 24 | 32.983 percent change | Standard Deviation 138.1448 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | C.tetani IgG Antibody: Change at Week24 | 19.517 percent change | Standard Deviation 194.1378 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 2 IgG AB: Change at Week 24 | -2.263 percent change | Standard Deviation 52.3214 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 22F IgG AB: Change at Week 24 | 11.419 percent change | Standard Deviation 127.0639 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 10A IgG AB: Change at Week 24 | 19.729 percent change | Standard Deviation 111.4367 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 6B IgG AB: Change at Week 24 | -8.215 percent change | Standard Deviation 36.4547 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 17F IgG AB: Change at Week 24 | 20.238 percent change | Standard Deviation 90.3348 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19F IgG AB: Change at Week 24 | 54.691 percent change | Standard Deviation 114.1882 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 11A IgG AB: Change at Week 24 | 51.134 percent change | Standard Deviation 146.864 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 33F IgG AB: Change at Week 24 | 2.245 percent change | Standard Deviation 65.726 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 4 IgG AB: Change at Week 24 | -8.039 percent change | Standard Deviation 43.2246 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 20 IgG AB: Change at Week 24 | 35.202 percent change | Standard Deviation 90.9529 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 12F IgG AB: Change at Week 24 | -4.445 percent change | Standard Deviation 72.6724 |
| Part A: Placebo | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 7F IgG AB: Change at Week 24 | -7.560 percent change | Standard Deviation 54.4647 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 12F IgG AB: Change at Week 24 | -5.463 percent change | Standard Deviation 105.9311 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19F IgG AB: Change at Week 24 | 5.412 percent change | Standard Deviation 83.2939 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 14 IgG AB: Change at Week 24 | -31.375 percent change | Standard Deviation 69.5715 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 15B IgG AB: Change at Week 24 | 17.353 percent change | Standard Deviation 66.5358 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19A IgG AB: Change at Week 24 | 44.814 percent change | Standard Deviation 73.1928 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 17F IgG AB: Change at Week 24 | 1.009 percent change | Standard Deviation 53.3534 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 18C IgG AB: Change at Week 24 | -14.827 percent change | Standard Deviation 57.5927 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 5 IgG AB: Change at Week 24 | 81.053 percent change | Standard Deviation 156.0747 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 2 IgG AB: Change at Week 24 | 17.857 percent change | Standard Deviation 64.1746 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 33F IgG AB: Change at Week 24 | -3.348 percent change | Standard Deviation 64.8128 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 6B IgG AB: Change at Week 24 | -7.761 percent change | Standard Deviation 68.319 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 1 IgG AB: Change at Week 24 | 2.996 percent change | Standard Deviation 56.3607 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 7F IgG AB: Change at Week 24 | 1.928 percent change | Standard Deviation 90.5777 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 23F IgG AB: Change at Week 24 | 18.204 percent change | Standard Deviation 57.8187 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 8 IgG AB: Change at Week 24 | -14.917 percent change | Standard Deviation 72.2397 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9N IgG AB: Change at Week 24 | 22.663 percent change | Standard Deviation 111.5069 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 3 IgG AB: Change at Week 24 | 530.405 percent change | Standard Deviation 1313.1947 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 22F IgG AB: Change at Week 24 | 23.828 percent change | Standard Deviation 108.3336 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9V IgG AB: Change at Week 24 | -3.399 percent change | Standard Deviation 47.7558 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | -50.000 percent change | Standard Deviation 70.7107 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 10A IgG AB: Change at Week 24 | 101.031 percent change | Standard Deviation 168.5588 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | C.tetani IgG Antibody: Change at Week24 | 39.032 percent change | Standard Deviation 83.7958 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 20 IgG AB: Change at Week 24 | -37.641 percent change | Standard Deviation 33.1824 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 11A IgG AB: Change at Week 24 | -16.656 percent change | Standard Deviation 93.114 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 4 IgG AB: Change at Week 24 | -15.385 percent change | Standard Deviation 70.4542 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 17F IgG AB: Change at Week 24 | -29.346 percent change | Standard Deviation 51.5854 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 1 IgG AB: Change at Week 24 | -10.403 percent change | Standard Deviation 40.9969 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 2 IgG AB: Change at Week 24 | -26.089 percent change | Standard Deviation 35.2991 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 3 IgG AB: Change at Week 24 | 16.282 percent change | Standard Deviation 89.2804 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 4 IgG AB: Change at Week 24 | -26.435 percent change | Standard Deviation 50.4316 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 5 IgG AB: Change at Week 24 | 2.937 percent change | Standard Deviation 88.0683 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 6B IgG AB: Change at Week 24 | -40.573 percent change | Standard Deviation 28.7097 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 7F IgG AB: Change at Week 24 | -27.272 percent change | Standard Deviation 30.2249 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 8 IgG AB: Change at Week 24 | -19.919 percent change | Standard Deviation 55.3947 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9N IgG AB: Change at Week 24 | 2.985 percent change | Standard Deviation 42.674 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9V IgG AB: Change at Week 24 | -13.591 percent change | Standard Deviation 34.6936 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 10A IgG AB: Change at Week 24 | 11.364 percent change | Standard Deviation 51.7417 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 11A IgG AB: Change at Week 24 | 14.976 percent change | Standard Deviation 131.8861 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 12F IgG AB: Change at Week 24 | -41.416 percent change | Standard Deviation 37.8396 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 14 IgG AB: Change at Week 24 | 2.213 percent change | Standard Deviation 83.1715 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 15B IgG AB: Change at Week 24 | -5.380 percent change | Standard Deviation 47.4598 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 18C IgG AB: Change at Week 24 | -30.608 percent change | Standard Deviation 35.7004 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19A IgG AB: Change at Week 24 | -16.275 percent change | Standard Deviation 73.1979 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19F IgG AB: Change at Week 24 | -20.778 percent change | Standard Deviation 54.8585 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 20 IgG AB: Change at Week 24 | -53.328 percent change | Standard Deviation 21.6352 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 22F IgG AB: Change at Week 24 | -27.150 percent change | Standard Deviation 51.7944 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 23F IgG AB: Change at Week 24 | 35.862 percent change | Standard Deviation 55.9954 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 33F IgG AB: Change at Week 24 | -47.069 percent change | Standard Deviation 32.3779 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | C.tetani IgG Antibody: Change at Week24 | 29.887 percent change | Standard Deviation 80.9696 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | 77.083 percent change | Standard Deviation 156.8461 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19F IgG AB: Change at Week 24 | 101.397 percent change | Standard Deviation 221.3435 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 11A IgG AB: Change at Week 24 | 18.956 percent change | Standard Deviation 90.1198 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 10A IgG AB: Change at Week 24 | 24.321 percent change | Standard Deviation 83.4616 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Diphtheria IgG Antibody: Change at Week 24 | -8.842 percent change | Standard Deviation 52.9312 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 20 IgG AB: Change at Week 24 | 75.407 percent change | Standard Deviation 168.3388 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9V IgG AB: Change at Week 24 | 56.445 percent change | Standard Deviation 189.5817 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 9N IgG AB: Change at Week 24 | 13.703 percent change | Standard Deviation 137.062 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | C.tetani IgG Antibody: Change at Week24 | -11.895 percent change | Standard Deviation 48.326 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 22F IgG AB: Change at Week 24 | 20.048 percent change | Standard Deviation 139.8965 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 8 IgG AB: Change at Week 24 | 13.552 percent change | Standard Deviation 54.9741 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 7F IgG AB: Change at Week 24 | 19.827 percent change | Standard Deviation 120.4336 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 2 IgG AB: Change at Week 24 | 2.207 percent change | Standard Deviation 57.5136 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 23F IgG AB: Change at Week 24 | 22.329 percent change | Standard Deviation 156.853 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 6B IgG AB: Change at Week 24 | 34.204 percent change | Standard Deviation 179.4443 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 5 IgG AB: Change at Week 24 | 23.064 percent change | Standard Deviation 57.0094 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 1 IgG AB: Change at Week 24 | 159.298 percent change | Standard Deviation 788.0577 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 17F IgG AB: Change at Week 24 | 51.187 percent change | Standard Deviation 152.3694 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 33F IgG AB: Change at Week 24 | 23.533 percent change | Standard Deviation 102.5771 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 18C IgG AB: Change at Week 24 | 43.454 percent change | Standard Deviation 218.7604 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 15B IgG AB: Change at Week 24 | 69.305 percent change | Standard Deviation 570.5864 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 4 IgG AB: Change at Week 24 | 26.481 percent change | Standard Deviation 143.2057 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 19A IgG AB: Change at Week 24 | 32.146 percent change | Standard Deviation 64.1971 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 14 IgG AB: Change at Week 24 | 20.278 percent change | Standard Deviation 136.8606 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 12F IgG AB: Change at Week 24 | -11.447 percent change | Standard Deviation 58.0173 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline in Vaccine Titers at Week 24 | Sero 3 IgG AB: Change at Week 24 | 51.000 percent change | Standard Deviation 205.2211 |
Secondary
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels
Time frame: Baseline up to Week 24
Population: Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | 1.86 percent change | Standard Deviation 19.22 |
| Part A: Placebo | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | 1.50 percent change | Standard Deviation 11.91 |
| Part A: Placebo | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | -1.51 percent change | Standard Deviation 18.94 |
| Part A: Placebo | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | 7.30 percent change | Standard Deviation 16.58 |
| Part A: Placebo | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | 6.86 percent change | Standard Deviation 19.2 |
| Part A: Placebo | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | 0.96 percent change | Standard Deviation 11.71 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | -6.73 percent change | Standard Deviation 12.57 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | -2.53 percent change | Standard Deviation 8.52 |
| Part A: BIIB059 50 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | -15.55 percent change | Standard Deviation 41.08 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | -14.99 percent change | Standard Deviation 11.74 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | -5.88 percent change | Standard Deviation 23.39 |
| Part A: BIIB059 150 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | -0.10 percent change | Standard Deviation 18.22 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 24 | 6.07 percent change | Standard Deviation 16.44 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | 2.63 percent change | Standard Deviation 15.23 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 24 | -0.48 percent change | Standard Deviation 12.94 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 24 | 0.87 percent change | Standard Deviation 45.16 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | -0.53 percent change | Standard Deviation 9.22 |
| Part A: BIIB059 450 mg | Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | -0.73 percent change | Standard Deviation 40.24 |
Secondary
Part A: Serum Concentration of BIIB059
Time frame: Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253
Population: The PK population included the safety participants who had at least 1 PK concentration measurement. The number analyzed is the number of participants with data available for analysis at the specified time point. The number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 1: Pre-dose | 0.0 nanogram per milliliter (ng/mL) | Standard Deviation 0 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 1: Post-dose | 0.7 nanogram per milliliter (ng/mL) | Standard Deviation 0.6 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 8 | 5.5 nanogram per milliliter (ng/mL) | Standard Deviation 2 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 29: Pre-dose | 7.0 nanogram per milliliter (ng/mL) | Standard Deviation 3.3 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 29: Post-dose | 7.9 nanogram per milliliter (ng/mL) | Standard Deviation 4.2 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 85: Pre-dose | 3.9 nanogram per milliliter (ng/mL) | Standard Deviation 1.6 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 113: Pre-dose | 3.4 nanogram per milliliter (ng/mL) | Standard Deviation 1.5 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 169 | 3.7 nanogram per milliliter (ng/mL) | Standard Deviation 1.5 |
| Part A: Placebo | Part A: Serum Concentration of BIIB059 | Day 197 | 0.9 nanogram per milliliter (ng/mL) | Standard Deviation 0.6 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 113: Pre-dose | 11.3 nanogram per milliliter (ng/mL) | Standard Deviation 5.2 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 85: Pre-dose | 12.7 nanogram per milliliter (ng/mL) | Standard Deviation 3.7 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 1: Pre-dose | 0.0 nanogram per milliliter (ng/mL) | Standard Deviation 0 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 29: Post-dose | 25.9 nanogram per milliliter (ng/mL) | Standard Deviation 5.6 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 253 | 0.4 nanogram per milliliter (ng/mL) | — |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 1: Post-dose | 2.1 nanogram per milliliter (ng/mL) | Standard Deviation 1.3 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 29: Pre-dose | 23.7 nanogram per milliliter (ng/mL) | Standard Deviation 7.2 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 169 | 12.8 nanogram per milliliter (ng/mL) | Standard Deviation 4.8 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 8 | 17.1 nanogram per milliliter (ng/mL) | Standard Deviation 4.1 |
| Part A: BIIB059 50 mg | Part A: Serum Concentration of BIIB059 | Day 197 | 4.1 nanogram per milliliter (ng/mL) | Standard Deviation 2.3 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 169 | 32.0 nanogram per milliliter (ng/mL) | Standard Deviation 18.6 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 8 | 45.5 nanogram per milliliter (ng/mL) | Standard Deviation 16.5 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 29: Pre-dose | 53.6 nanogram per milliliter (ng/mL) | Standard Deviation 19.7 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 253 | 2.8 nanogram per milliliter (ng/mL) | Standard Deviation 2.5 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 29: Post-dose | 52.5 nanogram per milliliter (ng/mL) | Standard Deviation 20.5 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 85: Pre-dose | 34.7 nanogram per milliliter (ng/mL) | Standard Deviation 19.1 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 85: Post-dose | 36.1 nanogram per milliliter (ng/mL) | Standard Deviation 23.2 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 197 | 12.6 nanogram per milliliter (ng/mL) | Standard Deviation 10.3 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 113: Pre-dose | 34.6 nanogram per milliliter (ng/mL) | Standard Deviation 20.8 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 1: Pre-dose | 0.0 nanogram per milliliter (ng/mL) | Standard Deviation 0 |
| Part A: BIIB059 150 mg | Part A: Serum Concentration of BIIB059 | Day 1: Post-dose | 1.9 nanogram per milliliter (ng/mL) | Standard Deviation 2.1 |
Secondary
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12
Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed.
Time frame: Baseline to Week 12
Population: Safety population included all randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, overall number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | C. tetani IgG Antibody: Baseline | 4.41 IU/mL | Standard Deviation 3.469 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | C. tetani IgG Antibody: Change at Week 12 | -0.61 IU/mL | Standard Deviation 1.178 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | Diphtheria IgG Antibody: Baseline | 0.46 IU/mL | Standard Deviation 0.465 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | Diphtheria IgG Antibody: Change at Week 12 | -0.01 IU/mL | Standard Deviation 0.146 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | Diphtheria IgG Antibody: Baseline | 0.10 IU/mL | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | C. tetani IgG Antibody: Baseline | 3.00 IU/mL | — |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | C. tetani IgG Antibody: Change at Week 12 | 1.20 IU/mL | Standard Deviation 6.948 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | Diphtheria IgG Antibody: Change at Week 12 | 0.06 IU/mL | Standard Deviation 0.875 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | C. tetani IgG Antibody: Baseline | 5.04 IU/mL | Standard Deviation 2.91 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12 | Diphtheria IgG Antibody: Baseline | 0.74 IU/mL | Standard Deviation 1.027 |
Secondary
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.
Time frame: Baseline to Week 12
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, overall number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 3 IgG AB: Baseline | 3.881 mg/L | Standard Deviation 7.0122 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 15B IgG AB: Baseline | 4.717 mg/L | Standard Deviation 9.7429 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9V IgG AB: Change at Week 12 | -0.001 mg/L | Standard Deviation 0.3491 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 14 IgG AB: Change at Week 12 | 1.3686 mg/L | Standard Deviation 5.66545 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 10A IgG AB: Baseline | 6.760 mg/L | Standard Deviation 10.6571 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 1 IgG AB: Change at Week 12 | 4.193 mg/L | Standard Deviation 9.8131 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 14 IgG AB: Baseline | 5.6435 mg/L | Standard Deviation 7.0987 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 10A IgG AB: Change at Week 12 | 1.833 mg/L | Standard Deviation 3.0611 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 12F IgG AB: Change at Week 12 | 1.1429 mg/L | Standard Deviation 2.54387 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 11A IgG AB: Baseline | 2.1860 mg/L | Standard Deviation 2.85529 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 22F IgG AB: Change at Week 12 | -1.8500 mg/L | Standard Deviation 4.69494 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 12F IgG AB: Baseline | 2.1680 mg/L | Standard Deviation 4.29056 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 11A IgG AB: Change at Week 12 | 0.6293 mg/L | Standard Deviation 3.04077 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 3 IgG AB: Change at Week 12 | -1.886 mg/L | Standard Deviation 5.467 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 22F IgG AB: Baseline | 5.9930 mg/L | Standard Deviation 10.47744 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 4 IgG AB: Baseline | 3.6185 mg/L | Standard Deviation 8.92846 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 33F IgG AB: Baseline | 5.500 mg/L | Standard Deviation 8.3404 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 20 IgG AB: Change at Week 12 | -0.2271 mg/L | Standard Deviation 5.08362 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 4 IgG AB: Change at Week 12 | 0.0571 mg/L | Standard Deviation 0.20934 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 20 IgG AB: Baseline | 11.5305 mg/L | Standard Deviation 18.12761 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 5 IgG AB: Baseline | 7.2845 mg/L | Standard Deviation 10.00019 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 2 IgG AB: Baseline | 4.7775 mg/L | Standard Deviation 10.24616 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19F IgG AB: Change at Week 12 | 2.3893 mg/L | Standard Deviation 4.24918 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 5 IgG AB: Change at Week 12 | 4.4443 mg/L | Standard Deviation 7.54015 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19F IgG AB: Baseline | 4.1040 mg/L | Standard Deviation 5.50276 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 6B IgG AB: Baseline | 10.7965 mg/L | Standard Deviation 29.02953 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 33F IgG AB: Change at Week 12 | -0.281 mg/L | Standard Deviation 0.4481 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19A IgG AB: Change at Week 12 | 3.4457 mg/L | Standard Deviation 6.31401 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 6B IgG AB: Change at Week 12 | 0.2943 mg/L | Standard Deviation 0.63629 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 1 IgG AB: Baseline | 3.538 mg/L | Standard Deviation 6.0374 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 7F IgG AB: Baseline | 2.482 mg/L | Standard Deviation 3.0844 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 23F IgG AB: Change at Week 12 | 1.9964 mg/L | Standard Deviation 5.10312 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19A IgG AB: Baseline | 24.5485 mg/L | Standard Deviation 44.24043 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 7F IgG AB: Change at Week 12 | 4.399 mg/L | Standard Deviation 10.6094 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 18C IgG AB: Change at Week 12 | 8.439 mg/L | Standard Deviation 21.2741 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 8 IgG AB: Baseline | 3.6820 mg/L | Standard Deviation 3.59284 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 2 IgG AB: Change at Week 12 | -0.4586 mg/L | Standard Deviation 0.72158 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 18C IgG AB: Baseline | 4.083 mg/L | Standard Deviation 6.6047 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 8 IgG AB: Change at Week 12 | 1.5329 mg/L | Standard Deviation 4.51498 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 17F IgG AB: Change at Week 12 | -2.0357 mg/L | Standard Deviation 4.29278 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9N IgG AB: Baseline | 4.1090 mg/L | Standard Deviation 6.77642 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 23F IgG AB: Baseline | 1.6980 mg/L | Standard Deviation 2.8193 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 17F IgG AB: Baseline | 16.0005 mg/L | Standard Deviation 15.82427 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9N IgG AB: Change at Week 12 | 3.3407 mg/L | Standard Deviation 8.5607 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 15B IgG AB: Change at Week 12 | 0.209 mg/L | Standard Deviation 0.2118 |
| Part A: Placebo | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9V IgG AB: Baseline | 1.104 mg/L | Standard Deviation 1.2697 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19A IgG AB: Baseline | 13.7700 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 1 IgG AB: Baseline | 0.210 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 2 IgG AB: Baseline | 0.9900 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 3 IgG AB: Baseline | 0.400 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 4 IgG AB: Baseline | 0.1000 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 5 IgG AB: Baseline | 3.3500 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 6B IgG AB: Baseline | 0.3600 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 7F IgG AB: Baseline | 0.660 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 8 IgG AB: Baseline | 0.2300 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9N IgG AB: Baseline | 0.1300 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9V IgG AB: Baseline | 0.070 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 10A IgG AB: Baseline | 2.140 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 11A IgG AB: Baseline | 0.3500 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 12F IgG AB: Baseline | 0.2700 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 14 IgG AB: Baseline | 8.9000 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 15B IgG AB: Baseline | 1.430 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 17F IgG AB: Baseline | 17.4500 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 18C IgG AB: Baseline | 0.140 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19F IgG AB: Baseline | 2.0500 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 20 IgG AB: Baseline | 0.7900 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 22F IgG AB: Baseline | 0.6700 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 23F IgG AB: Baseline | 0.5600 mg/L | — |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 33F IgG AB: Baseline | 0.220 mg/L | — |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 14 IgG AB: Change at Week 12 | -1.0319 mg/L | Standard Deviation 3.43469 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9V IgG AB: Baseline | 1.520 mg/L | Standard Deviation 2.4346 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 23F IgG AB: Baseline | 1.9957 mg/L | Standard Deviation 2.72717 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 15B IgG AB: Baseline | 3.410 mg/L | Standard Deviation 3.5117 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9N IgG AB: Change at Week 12 | 0.5875 mg/L | Standard Deviation 1.62657 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 15B IgG AB: Change at Week 12 | 0.624 mg/L | Standard Deviation 1.4874 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9N IgG AB: Baseline | 2.0848 mg/L | Standard Deviation 2.59536 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 2 IgG AB: Baseline | 3.9669 mg/L | Standard Deviation 8.68701 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 17F IgG AB: Baseline | 6.8752 mg/L | Standard Deviation 9.02378 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 8 IgG AB: Change at Week 12 | 0.5931 mg/L | Standard Deviation 1.32472 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 17F IgG AB: Change at Week 12 | 1.4531 mg/L | Standard Deviation 3.87924 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 8 IgG AB: Baseline | 2.6629 mg/L | Standard Deviation 3.61369 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 23F IgG AB: Change at Week 12 | 0.2775 mg/L | Standard Deviation 0.60481 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 18C IgG AB: Baseline | 5.630 mg/L | Standard Deviation 7.8627 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 7F IgG AB: Change at Week 12 | 0.796 mg/L | Standard Deviation 1.865 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 18C IgG AB: Change at Week 12 | 0.077 mg/L | Standard Deviation 1.0131 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 7F IgG AB: Baseline | 3.030 mg/L | Standard Deviation 2.6854 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 6B IgG AB: Change at Week 12 | 0.2738 mg/L | Standard Deviation 1.4978 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19A IgG AB: Baseline | 16.5624 mg/L | Standard Deviation 15.27894 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 6B IgG AB: Baseline | 2.9210 mg/L | Standard Deviation 4.10508 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19A IgG AB: Change at Week 12 | 5.3575 mg/L | Standard Deviation 8.84223 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 5 IgG AB: Change at Week 12 | 3.4794 mg/L | Standard Deviation 5.30014 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 1 IgG AB: Change at Week 12 | 0.116 mg/L | Standard Deviation 0.4689 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19F IgG AB: Baseline | 3.3800 mg/L | Standard Deviation 3.26583 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 5 IgG AB: Baseline | 5.0124 mg/L | Standard Deviation 5.8333 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 19F IgG AB: Change at Week 12 | 1.2275 mg/L | Standard Deviation 2.0555 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 4 IgG AB: Change at Week 12 | 0.0450 mg/L | Standard Deviation 0.63581 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 33F IgG AB: Change at Week 12 | 0.203 mg/L | Standard Deviation 1.4614 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 20 IgG AB: Baseline | 8.2971 mg/L | Standard Deviation 8.28676 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 4 IgG AB: Baseline | 1.2376 mg/L | Standard Deviation 1.90643 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 20 IgG AB: Change at Week 12 | -1.6638 mg/L | Standard Deviation 6.48421 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 3 IgG AB: Change at Week 12 | 0.307 mg/L | Standard Deviation 0.7307 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 33F IgG AB: Baseline | 4.245 mg/L | Standard Deviation 4.6106 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 22F IgG AB: Baseline | 3.8002 mg/L | Standard Deviation 6.40547 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 3 IgG AB: Baseline | 1.133 mg/L | Standard Deviation 1.0457 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 22F IgG AB: Change at Week 12 | 1.8431 mg/L | Standard Deviation 5.04651 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 11A IgG AB: Change at Week 12 | 0.6431 mg/L | Standard Deviation 1.74757 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 11A IgG AB: Baseline | 3.5831 mg/L | Standard Deviation 4.19998 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 2 IgG AB: Change at Week 12 | -0.4734 mg/L | Standard Deviation 4.04649 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 12F IgG AB: Baseline | 1.2424 mg/L | Standard Deviation 1.21257 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 10A IgG AB: Change at Week 12 | 4.696 mg/L | Standard Deviation 13.8354 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 12F IgG AB: Change at Week 12 | 0.3638 mg/L | Standard Deviation 0.72331 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 10A IgG AB: Baseline | 6.600 mg/L | Standard Deviation 9.0014 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 1 IgG AB: Baseline | 1.930 mg/L | Standard Deviation 2.6639 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 14 IgG AB: Baseline | 11.0210 mg/L | Standard Deviation 12.99039 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12 | Sero 9V IgG AB: Change at Week 12 | -0.181 mg/L | Standard Deviation 0.9893 |
Secondary
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels
Time frame: Baseline up to Week 16
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Baseline | 0.978 g/L | Standard Deviation 0.553 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 12 | -0.009 g/L | Standard Deviation 0.061 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | -0.016 g/L | Standard Deviation 0.125 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Baseline | 3.341 g/L | Standard Deviation 1.113 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Baseline | 13.480 g/L | Standard Deviation 4.193 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 12 | -0.029 g/L | Standard Deviation 0.249 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 12 | 0.120 g/L | Standard Deviation 0.662 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | 0.450 g/L | Standard Deviation 3.366 |
| Part A: Placebo | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | -0.045 g/L | Standard Deviation 0.432 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Baseline | 3.873 g/L | Standard Deviation 1.663 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Baseline | 0.880 g/L | Standard Deviation 0.563 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Baseline | 14.087 g/L | Standard Deviation 4.285 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | -0.117 g/L | Standard Deviation 0.356 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | -0.776 g/L | Standard Deviation 1.405 |
| Part A: BIIB059 50 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | -0.072 g/L | Standard Deviation 0.119 |
| Part A: BIIB059 150 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | -0.045 g/L | Standard Deviation 0.217 |
| Part A: BIIB059 150 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | -0.016 g/L | Standard Deviation 0.376 |
| Part A: BIIB059 150 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | -0.084 g/L | Standard Deviation 3.975 |
| Part A: BIIB059 150 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Baseline | 13.700 g/L | Standard Deviation 5.397 |
| Part A: BIIB059 150 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Baseline | 1.095 g/L | Standard Deviation 0.656 |
| Part A: BIIB059 150 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Baseline | 2.900 g/L | Standard Deviation 1.705 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 16 | -0.035 g/L | Standard Deviation 0.15 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Baseline | 3.061 g/L | Standard Deviation 1.413 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 12 | -0.304 g/L | Standard Deviation 0.711 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgA: Change at Week 16 | -0.076 g/L | Standard Deviation 0.254 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Baseline | 14.874 g/L | Standard Deviation 5.904 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 12 | -1.961 g/L | Standard Deviation 4.312 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgG: Change at Week 16 | -0.064 g/L | Standard Deviation 1.375 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Baseline | 0.993 g/L | Standard Deviation 0.757 |
| Part A: BIIB059 450 mg | Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels | IgM: Change at Week 12 | -0.028 g/L | Standard Deviation 0.096 |
Secondary
Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
Time frame: Baseline up to Week 28
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
| Part A: BIIB059 50 mg | Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
| Part A: BIIB059 150 mg | Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
| Part A: BIIB059 450 mg | Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | 0 Participants |
Secondary
Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Baseline up to Week 28
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
| Part A: BIIB059 50 mg | Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
| Part A: BIIB059 150 mg | Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
| Part A: BIIB059 450 mg | Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | 0 Participants |
Secondary
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Baseline up to Week 28
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
| Part A: BIIB059 50 mg | Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
| Part A: BIIB059 150 mg | Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
| Part A: BIIB059 450 mg | Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | 0 Participants |
Secondary
Part B: Number of Participants With Positive BIIB059 Antibodies
Time frame: Baseline up to Week 16
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Positive BIIB059 Antibodies | 0 Participants |
| Part A: BIIB059 50 mg | Part B: Number of Participants With Positive BIIB059 Antibodies | 5 Participants |
| Part A: BIIB059 150 mg | Part B: Number of Participants With Positive BIIB059 Antibodies | 4 Participants |
| Part A: BIIB059 450 mg | Part B: Number of Participants With Positive BIIB059 Antibodies | 5 Participants |
Secondary
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Time frame: Baseline up to Week 28
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 22 Participants |
| Part A: Placebo | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Part A: BIIB059 50 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Part A: BIIB059 50 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 18 Participants |
| Part A: BIIB059 150 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 15 Participants |
| Part A: BIIB059 150 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Part A: BIIB059 450 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 38 Participants |
| Part A: BIIB059 450 mg | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
Secondary
Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=4-point reduction from baseline in CLASI-A score are reported here.
Time frame: Week 12, Week 16
Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Placebo | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 33.33 percentage of participants |
| Part A: Placebo | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 37.50 percentage of participants |
| Part A: BIIB059 50 mg | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 46.15 percentage of participants |
| Part A: BIIB059 50 mg | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 50.00 percentage of participants |
| Part A: BIIB059 150 mg | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 76.00 percentage of participants |
| Part A: BIIB059 150 mg | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 72.00 percentage of participants |
| Part A: BIIB059 450 mg | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 47.92 percentage of participants |
| Part A: BIIB059 450 mg | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 55.81 percentage of participants |
Secondary
Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=7-point reduction from baseline in CLASI-A score are reported here.
Time frame: Week 12, Week 16
Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Placebo | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 18.18 percentage of participants |
| Part A: Placebo | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 21.88 percentage of participants |
| Part A: BIIB059 50 mg | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 30.77 percentage of participants |
| Part A: BIIB059 50 mg | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 38.46 percentage of participants |
| Part A: BIIB059 150 mg | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 40.00 percentage of participants |
| Part A: BIIB059 150 mg | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 48.00 percentage of participants |
| Part A: BIIB059 450 mg | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12 | 33.33 percentage of participants |
| Part A: BIIB059 450 mg | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 16 | 41.86 percentage of participants |
Secondary
Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Time frame: Week 12, Week 16
Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: Placebo | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 12 | 12.12 percentage of participants |
| Part A: Placebo | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 16 | 21.88 percentage of participants |
| Part A: BIIB059 50 mg | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 16 | 38.46 percentage of participants |
| Part A: BIIB059 50 mg | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 12 | 38.46 percentage of participants |
| Part A: BIIB059 150 mg | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 12 | 48.00 percentage of participants |
| Part A: BIIB059 150 mg | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 16 | 44.00 percentage of participants |
| Part A: BIIB059 450 mg | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 12 | 37.50 percentage of participants |
| Part A: BIIB059 450 mg | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 16 | 46.51 percentage of participants |
Secondary
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Time frame: Baseline, Week 12
Population: MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participant analyzed in this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part A: Placebo | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 | -10.73 percent change | Standard Deviation 34.41 |
| Part A: BIIB059 50 mg | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 | -38.72 percent change | Standard Deviation 32.99 |
| Part A: BIIB059 150 mg | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 | -47.82 percent change | Standard Deviation 31.8 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 | -35.25 percent change | Standard Deviation 35.77 |
Comparison: A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.p-value: 0.00195% CI: [-48.75, -11.97]MMRM
Comparison: A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.p-value: <0.00195% CI: [-55.46, -18.87]MMRM
Comparison: A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.p-value: 0.00195% CI: [-41.71, -10.4]MMRM
Secondary
Part B: Percent Change From Baseline in Vaccine Titers at Week 12
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody.
Time frame: Baseline to Week 12
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, overall number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 3 IgG AB: Change at Week 12 | -3.370 percent change | Standard Deviation 38.0473 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 14 IgG AB: Change at Week 12 | 77.551 percent change | Standard Deviation 191.9769 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 8 IgG AB: Change at Week 12 | 28.981 percent change | Standard Deviation 76.3568 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 15B IgG AB: Change at Week 12 | 14.160 percent change | Standard Deviation 16.804 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 5 IgG AB: Change at Week 12 | 39.578 percent change | Standard Deviation 34.1628 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 17F IgG AB: Change at Week 12 | -14.128 percent change | Standard Deviation 20.3094 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 9N IgG AB: Change at Week 12 | 18.274 percent change | Standard Deviation 61.3305 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 18C IgG AB: Change at Week 12 | 36.970 percent change | Standard Deviation 99.7771 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 2 IgG AB: Change at Week 12 | -20.725 percent change | Standard Deviation 23.3306 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 19A IgG AB: Change at Week 12 | 15.179 percent change | Standard Deviation 28.0371 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 9V IgG AB: Change at Week 12 | -7.707 percent change | Standard Deviation 27.1098 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 19F IgG AB: Change at Week 12 | 54.773 percent change | Standard Deviation 49.4505 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 6B IgG AB: Change at Week 12 | 11.800 percent change | Standard Deviation 36.9732 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 20 IgG AB: Change at Week 12 | 1.131 percent change | Standard Deviation 51.4091 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 10A IgG AB: Change at Week 12 | 62.824 percent change | Standard Deviation 94.6871 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 22F IgG AB: Change at Week 12 | -14.748 percent change | Standard Deviation 45.9399 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 4 IgG AB: Change at Week 12 | 6.349 percent change | Standard Deviation 31.2778 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 23F IgG AB: Change at Week 12 | 52.210 percent change | Standard Deviation 75.6486 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 11A IgG AB: Change at Week 12 | 12.392 percent change | Standard Deviation 69.6069 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 33F IgG AB: Change at Week 12 | 0.600 percent change | Standard Deviation 31.44 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 7F IgG AB: Change at Week 12 | 67.784 percent change | Standard Deviation 90.5075 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | C. tetani IgG Antibody: Change at Week 12 | -6.387 percent change | Standard Deviation 18.2069 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 12F IgG AB: Change at Week 12 | 21.768 percent change | Standard Deviation 44.1688 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Diphtheria IgG Antibody: Change at Week 12 | 0.000 percent change | Standard Deviation 34.0588 |
| Part A: Placebo | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 1 IgG AB: Change at Week 12 | 16.835 percent change | Standard Deviation 59.1269 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Diphtheria IgG Antibody: Change at Week 12 | 28.845 percent change | Standard Deviation 132.2208 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 1 IgG AB: Change at Week 12 | 4.257 percent change | Standard Deviation 67.8533 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 2 IgG AB: Change at Week 12 | 15.437 percent change | Standard Deviation 65.9854 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 3 IgG AB: Change at Week 12 | 40.604 percent change | Standard Deviation 72.3862 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 4 IgG AB: Change at Week 12 | 32.033 percent change | Standard Deviation 125.5527 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 5 IgG AB: Change at Week 12 | 68.850 percent change | Standard Deviation 127.9989 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 6B IgG AB: Change at Week 12 | 43.759 percent change | Standard Deviation 97.2095 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 7F IgG AB: Change at Week 12 | 25.297 percent change | Standard Deviation 48.343 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 8 IgG AB: Change at Week 12 | 41.622 percent change | Standard Deviation 84.829 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 9N IgG AB: Change at Week 12 | 19.616 percent change | Standard Deviation 74.2945 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 9V IgG AB: Change at Week 12 | -0.573 percent change | Standard Deviation 35.9671 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 10A IgG AB: Change at Week 12 | 60.437 percent change | Standard Deviation 145.3385 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 11A IgG AB: Change at Week 12 | 29.295 percent change | Standard Deviation 118.2639 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 12F IgG AB: Change at Week 12 | 62.768 percent change | Standard Deviation 118.4103 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 14 IgG AB: Change at Week 12 | 18.059 percent change | Standard Deviation 75.7757 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 15B IgG AB: Change at Week 12 | 27.188 percent change | Standard Deviation 56.4211 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 17F IgG AB: Change at Week 12 | 19.712 percent change | Standard Deviation 69.9092 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 18C IgG AB: Change at Week 12 | 8.882 percent change | Standard Deviation 41.3781 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 19A IgG AB: Change at Week 12 | 44.140 percent change | Standard Deviation 113.578 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 19F IgG AB: Change at Week 12 | 46.995 percent change | Standard Deviation 90.7514 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 20 IgG AB: Change at Week 12 | 0.714 percent change | Standard Deviation 49.6361 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 22F IgG AB: Change at Week 12 | 38.974 percent change | Standard Deviation 83.4963 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 23F IgG AB: Change at Week 12 | 16.859 percent change | Standard Deviation 40.1773 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | Sero 33F IgG AB: Change at Week 12 | 26.241 percent change | Standard Deviation 66.5051 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline in Vaccine Titers at Week 12 | C. tetani IgG Antibody: Change at Week 12 | 27.872 percent change | Standard Deviation 128.3927 |
Secondary
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels
Time frame: Baseline up to Week 16
Population: Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, number analyzed signifies number of participants analyzed at specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig G: Change at Week 12 | 0.63 percent change | Standard Deviation 5.76 |
| Part A: Placebo | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig G: Change at Week 16 | 2.48 percent change | Standard Deviation 19.59 |
| Part A: Placebo | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig A: Change at Week 16 | -1.32 percent change | Standard Deviation 12.92 |
| Part A: Placebo | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig M: Change at Week 16 | -3.62 percent change | Standard Deviation 10.84 |
| Part A: Placebo | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig M: Change at Week 12 | -1.25 percent change | Standard Deviation 4.98 |
| Part A: Placebo | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig A: Change at Week 12 | -1.45 percent change | Standard Deviation 7.14 |
| Part A: BIIB059 50 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig G: Change at Week 16 | -3.84 percent change | Standard Deviation 11.14 |
| Part A: BIIB059 50 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig A: Change at Week 16 | -1.48 percent change | Standard Deviation 10.13 |
| Part A: BIIB059 50 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig M: Change at Week 16 | -7.60 percent change | Standard Deviation 12.86 |
| Part A: BIIB059 150 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig G: Change at Week 16 | 1.05 percent change | Standard Deviation 18.28 |
| Part A: BIIB059 150 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig M: Change at Week 16 | -1.25 percent change | Standard Deviation 22.27 |
| Part A: BIIB059 150 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig A: Change at Week 16 | 0.19 percent change | Standard Deviation 14.22 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig A: Change at Week 12 | -5.11 percent change | Standard Deviation 14.44 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig M: Change at Week 16 | -0.57 percent change | Standard Deviation 11.85 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig A: Change at Week 16 | -2.98 percent change | Standard Deviation 7.64 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig G: Change at Week 12 | -8.40 percent change | Standard Deviation 18.97 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig G: Change at Week 16 | -0.39 percent change | Standard Deviation 9.81 |
| Part A: BIIB059 450 mg | Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels | Ig M: Change at Week 12 | -1.22 percent change | Standard Deviation 18.25 |
Secondary
Part B: Serum Concentration of BIIB059
Time frame: Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197
Population: The PK population included the safety participants who had at least 1 PK concentration measurement. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 113 | 4.6 ng/mL | Standard Deviation 5.9 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 29: Post-dose | 8.7 ng/mL | Standard Deviation 6.6 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 1: Pre-dose | 0.0 ng/mL | Standard Deviation 0.1 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 85: Post-dose | 4.1 ng/mL | Standard Deviation 3.6 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 85: Pre-dose | 3.8 ng/mL | Standard Deviation 3.4 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 169 | 2.4 ng/mL | Standard Deviation 2 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 8 | 6.8 ng/mL | Standard Deviation 6.6 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 197 | 0.8 ng/mL | Standard Deviation 0.7 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 141 | 2.5 ng/mL | Standard Deviation 3.3 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 29: Pre-dose | 8.3 ng/mL | Standard Deviation 7.1 |
| Part A: Placebo | Part B: Serum Concentration of BIIB059 | Day 1: Post-dose | 0.4 ng/mL | Standard Deviation 0.3 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 1: Pre-dose | 0.1 ng/mL | Standard Deviation 0.2 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 1: Post-dose | 1.1 ng/mL | Standard Deviation 1.1 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 8 | 13.3 ng/mL | Standard Deviation 6.1 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 29: Pre-dose | 16.9 ng/mL | Standard Deviation 9.1 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 29: Post-dose | 17.6 ng/mL | Standard Deviation 10.2 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 85: Pre-dose | 11.0 ng/mL | Standard Deviation 6.5 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 85: Post-dose | 11.6 ng/mL | Standard Deviation 5.8 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 113 | 12.1 ng/mL | Standard Deviation 6.5 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 141 | 4.6 ng/mL | Standard Deviation 3.7 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 169 | 2.2 ng/mL | Standard Deviation 1.1 |
| Part A: BIIB059 50 mg | Part B: Serum Concentration of BIIB059 | Day 197 | 1.1 ng/mL | Standard Deviation 0.4 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 169 | 7.4 ng/mL | Standard Deviation 5 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 113 | 43.2 ng/mL | Standard Deviation 14.3 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 8 | 47.8 ng/mL | Standard Deviation 16.9 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 1: Pre-dose | 0.0 ng/mL | Standard Deviation 0.1 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 141 | 19.3 ng/mL | Standard Deviation 9.6 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 1: Post-dose | 2.9 ng/mL | Standard Deviation 3.7 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 85: Pre-dose | 42.0 ng/mL | Standard Deviation 17.1 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 29: Post-dose | 61.0 ng/mL | Standard Deviation 24.2 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 197 | 3.4 ng/mL | Standard Deviation 2.3 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 85: Post-dose | 42.0 ng/mL | Standard Deviation 17 |
| Part A: BIIB059 150 mg | Part B: Serum Concentration of BIIB059 | Day 29: Pre-dose | 60.2 ng/mL | Standard Deviation 23.3 |