Dermatomyositis
Conditions
Brief summary
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.
Interventions
human immunoglobulin G administered subcutaneously
DRUGPlacebo
contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects ≥ 18 years of age * Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure * Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14. * Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent
Exclusion criteria
* Cancer-associated myositis * Evidence of active malignant disease or malignancies diagnosed within the previous 5 years * Physician Global Damage score ≥ 3, or clinically relevant improvement between Screening Visit and Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | At Week 25 | A responder was defined as a participant with a TIS \>= 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS was a sum response criterion which incorporates 6 weighted international myositis assessment and clinical studies (IMACS) core set measures (CSMs) including Physician and Patient Global Disease Activity (PGA), Manual Muscle Testing-8 (MMT-8), Health Assessment Questionnaire, Muscle Enzyme, and Extramuscular Global Activity (EGA). Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Percentage of responders at Week 25 based on TIS are reported here. Multiple imputation (MI) was used to impute missing values for participants who discontinued due to the military activities in Ukraine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes From Baseline in MMT-8 | From Baseline to Week 25 | The MMT-8 was a set of 8 designated muscles which were tested bilaterally (potential score ranging from 0 to 150): 7 biaxial muscles with a potential score 0 to 140 and 1 axial (neck flexors) with a potential score of 0 to 10. Improvement is documented with an increase in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, and region as fixed effects, baseline MMT-8 as a continuous covariate and participant as a random effect. |
| Mean Changes From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Total Activity Score (CDASI-A) | From Baseline to Week 25 | The CDASI in its modified version 2 (V2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (\<=142 points vs \>142 points) as fixed effects, baseline CDASI-A as a continuous covariate, and participants as a random effect. |
| Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25% | At Week 25 | Reduction in corticosteroid dose. |
| Period 1: Mean TIS at Each Visit | At Week 5, 9, 13, 17, 21, and 25 | The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points on the TIS. |
| Period 2: Mean TIS at Each Visit | Week 25, 29, 33, 37, 41, 45, 49, and 53 | The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points on the TIS. |
| Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | At Week 5, 9, 13, 17, 21, and 25 | Participants were considered and reported in more than one category (TIS \>= 20, \>= 40 and \>= 60 Points). |
| Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25, 29, 33, 37, 41, 45, 49, and 53 | Participants were considered and reported in more than one category (TIS \>= 20, \>= 40 and \>= 60 Points). |
| Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS | Up to Week 25 | The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period. |
| Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS | Up to Week 53 | The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period. |
| Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | From Baseline to Week 25 | Individual CSMs included following: Myositis Disease Activity Assessment Tool (MDAAT) Physician global disease activity (PGDA), PGA assessment, MMT-8, health assessment questionnaire-disability index (HAQ-DI), and MDAAT-EGA. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100). |
| Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | From Week 25 to Week 53 | Individual CSMs included following: MDAAT-PGDA, PGA assessment, MMT-8, HAQ-DI, and MDAAT extramacular global assessment. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100). |
| Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice | Up to Week 25 | The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment Visual Analog Scale (VAS) worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) |
| Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | Up to Week 25 | The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) |
| Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice | From Week 25 up to Week 53 | The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) |
| Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | From Week 25 up to Week 53 | The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) |
| Time to Meeting DOW for the First Time | Up to Week 53 | The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The observation was censored if no DOW was observed before the intake of rescue treatment or before the end of the period. |
| Mean TIS | At Week 25 | The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100; higher the score, better the condition), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Least squares (LS) means were estimated using a mixed model repeated measures (MMRM) including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (\<=142 points vs \>142 points) as fixed effects, participant as a random effect. |
| Percentage of Participants Meeting DOW and Receiving Rescue Steroid Treatment | Up to Week 25 | The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The percentage of participants meeting DOW and who received rescue steroid treatment are reported here. |
| Number of Participants Who Start Oral Corticosteroid Dose Taper | Up to Week 25 | — |
| Percentage of Participants Who Start Oral Corticosteroid Dose Taper | Up to Week 25 | — |
| Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Up to Week 25 and 52 | — |
| Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Up to Week 25 and 52 | — |
| Percentage of Participants Receiving Rescue Corticosteroid Treatment | Up to Week 25 | — |
| Percentage of Participants Whose Rescue Corticosteroid Treatment is Tapered | Up to Week 25 | — |
| Time to First Intake of Rescue Corticosteroid Treatment | Up to Week 25 | The observation was censored if no Rescue was observed before the last day of the last week with IMP intake or before the end of the period. |
| Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | From Baseline to Week 13 and 25 | EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure. |
| Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | From Baseline to Week 13 and 25 | EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure. |
| Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | From Week 25 to 41 and 53 | EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure. |
| Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | From Week 25 to 41 and 53 | EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure. |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Up to 5 years | — |
| Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Up to 5 years | — |
| Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Up to 5 years | — |
| Number of Participants Meeting DOW and Receiving Rescue Steroid Treatment | Up to Week 25 | The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The Number of participants meeting DOW and who received rescue steroid treatment are reported here. |
Countries
Argentina, Belgium, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Switzerland, Ukraine, United States
Participant flow
Recruitment details
This study was conducted from 21 October 2019 to 02 December 2024.
Pre-assignment details
A total of 199 participants were screened, and 65 of these were screen failures. A total of 134 were randomized in the study. This study consisted of 3 study periods (SP): SP1 (from Baseline to Week 25), SP2 (from Week 25 to 56) and SP3 (from Week 56 to approximately 5 years, study drug reimbursement was planned until drug becomes commercially available or if there is no longer benefit from the study drug). However, the study was terminated early.
Participants by arm
| Arm | Count |
|---|---|
| IgPro20 Participants received IgPro20 SC infusions weekly for 24 weeks in Period 1. | 67 |
| Placebo Participants received matching placebo SC infusions weekly for 24 weeks in Period 1. | 67 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 4 | 2 |
| Period 1 | Death | 1 | 1 |
| Period 1 | Lack of Efficacy | 1 | 1 |
| Period 1 | Other: Unspecified | 1 | 0 |
| Period 1 | Physician Decision | 0 | 1 |
| Period 1 | Protocol Deviation | 2 | 0 |
| Period 1 | Site Terminated by Sponsor | 0 | 1 |
| Period 1 | Study Terminated by Sponsor | 0 | 1 |
| Period 1 | Withdrawal by Subject | 2 | 5 |
| Period 2 | Adverse Event | 0 | 1 |
| Period 2 | Death | 1 | 0 |
| Period 2 | Lack of Efficacy | 0 | 1 |
| Period 2 | Lost to Follow-up | 0 | 1 |
| Period 2 | Other: Unspecified | 1 | 1 |
| Period 2 | Physician Decision | 0 | 2 |
| Period 2 | Site Terminated by Sponsor | 1 | 3 |
| Period 2 | Study Terminated by Sponsor | 8 | 3 |
| Period 2 | Withdrawal by Subject | 5 | 5 |
| Period 3 | Missing | 0 | 2 |
| Period 3 | Site Terminated by Sponsor | 1 | 2 |
| Period 3 | Study Terminated by Sponsor | 24 | 18 |
Baseline characteristics
| Characteristic | Placebo | Total | IgPro20 |
|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 14.02 | 50.3 years STANDARD_DEVIATION 14.96 | 51.5 years STANDARD_DEVIATION 15.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 29 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 100 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 10 Participants | 20 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants | 12 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 50 Participants | 98 Participants | 48 Participants |
| Sex: Female, Male Female | 51 Participants | 98 Participants | 47 Participants |
| Sex: Female, Male Male | 16 Participants | 36 Participants | 20 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 67 | 1 / 67 | 1 / 56 | 0 / 55 | 0 / 36 | 1 / 34 |
| other Total, other adverse events | 41 / 67 | 33 / 67 | 25 / 56 | 33 / 55 | 21 / 36 | 17 / 34 |
| serious Total, serious adverse events | 3 / 67 | 5 / 67 | 2 / 56 | 3 / 55 | 5 / 36 | 7 / 34 |
Outcome results
Primary
Responder Rate
A responder was defined as a participant with a TIS \>= 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or 21), who completes 24 weeks of randomized IMP treatment without the use of rescue corticosteroid treatment. The TIS was a sum response criterion which incorporates 6 weighted international myositis assessment and clinical studies (IMACS) core set measures (CSMs) including Physician and Patient Global Disease Activity (PGA), Manual Muscle Testing-8 (MMT-8), Health Assessment Questionnaire, Muscle Enzyme, and Extramuscular Global Activity (EGA). Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Percentage of responders at Week 25 based on TIS are reported here. Multiple imputation (MI) was used to impute missing values for participants who discontinued due to the military activities in Ukraine.
Time frame: At Week 25
Population: Analysis was performed on the modified intent-to-treat (mITT) analysis set. The mITT analysis set comprises all participants who underwent study screening procedures, were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP or the lack of any post randomization efficacy data lead to the exclusion of the participant from the mITT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 | Responder Rate | 64.3 percentage of participants |
| Placebo | Responder Rate | 61.6 percentage of participants |
p-value: 0.37100895% CI: [0.551, 2.309]Regression, Logistic
Secondary
Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk
Time frame: Up to 5 years
Population: Period 1: SAF: All randomized participants who received any IMP, analyzed by actual treatment. Period 2: SAF-EX: Participants from SAF who completed 24 weeks in Period 1 and received any IMP in Period 2. Period 3: SAF-P3: Participants from SAF-EX who completed 52 weeks in Periods 1 and 2 and received any IMP after Week 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Moderate | 2.145 TEAEs per year |
| IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Severe | 0.393 TEAEs per year |
| IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Mild | 9.151 TEAEs per year |
| Placebo | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Moderate | 1.162 TEAEs per year |
| Placebo | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Severe | 0.161 TEAEs per year |
| Placebo | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Mild | 4.035 TEAEs per year |
| Period 2 Sequence A: IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Severe | 0.067 TEAEs per year |
| Period 2 Sequence A: IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Mild | 4.011 TEAEs per year |
| Period 2 Sequence A: IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Moderate | 0.843 TEAEs per year |
| Period 2 Sequence B: Placebo / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Mild | 4.332 TEAEs per year |
| Period 2 Sequence B: Placebo / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Moderate | 2.239 TEAEs per year |
| Period 2 Sequence B: Placebo / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Severe | 0.110 TEAEs per year |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Severe | 0.117 TEAEs per year |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Mild | 2.442 TEAEs per year |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Moderate | 0.606 TEAEs per year |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Moderate | 1.390 TEAEs per year |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Mild | 2.157 TEAEs per year |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Annualized Rate of Mild, Moderate, and Severe TEAEs Per Time at Risk | Severe | 0.096 TEAEs per year |
Secondary
Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk
Time frame: Up to 5 years
Population: Period 1: SAF: All randomized participants who received any IMP, analyzed by actual treatment. Period 2: SAF-EX: Participants from SAF who completed 24 weeks in Period 1 and received any IMP in Period 2. Period 3: SAF-P3: Participants from SAF-EX who completed 52 weeks in Periods 1 and 2 and received any IMP after Week 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Related TEAEs | 6.327 TEAEs per year |
| IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | TEAEs | 11.725 TEAEs per year |
| IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Serious TEAEs | 0.214 TEAEs per year |
| Placebo | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Related TEAEs | 0.936 TEAEs per year |
| Placebo | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | TEAEs | 5.359 TEAEs per year |
| Placebo | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Serious TEAEs | 0.226 TEAEs per year |
| Period 2 Sequence A: IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Related TEAEs | 1.348 TEAEs per year |
| Period 2 Sequence A: IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | TEAEs | 4.922 TEAEs per year |
| Period 2 Sequence A: IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Serious TEAEs | 0.067 TEAEs per year |
| Period 2 Sequence B: Placebo / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Related TEAEs | 2.166 TEAEs per year |
| Period 2 Sequence B: Placebo / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | TEAEs | 6.718 TEAEs per year |
| Period 2 Sequence B: Placebo / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Serious TEAEs | 0.110 TEAEs per year |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Related TEAEs | 0.195 TEAEs per year |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | TEAEs | 3.165 TEAEs per year |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Serious TEAEs | 0.137 TEAEs per year |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | TEAEs | 3.644 TEAEs per year |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Serious TEAEs | 0.288 TEAEs per year |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Annualized Rate of TEAEs, Related TEAEs and Serious TEAEs Per Time at Risk | Related TEAEs | 0.240 TEAEs per year |
Secondary
Mean Changes From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Total Activity Score (CDASI-A)
The CDASI in its modified version 2 (V2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (\<=142 points vs \>142 points) as fixed effects, baseline CDASI-A as a continuous covariate, and participants as a random effect.
Time frame: From Baseline to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| IgPro20 | Mean Changes From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Total Activity Score (CDASI-A) | -10.6 score on a scale |
| Placebo | Mean Changes From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Total Activity Score (CDASI-A) | -5.3 score on a scale |
p-value: 0.00164795% CI: [-8.72, -1.82]MMRM
Secondary
Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI
Individual CSMs included following: Myositis Disease Activity Assessment Tool (MDAAT) Physician global disease activity (PGDA), PGA assessment, MMT-8, health assessment questionnaire-disability index (HAQ-DI), and MDAAT-EGA. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).
Time frame: From Baseline to Week 25
Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IgPro20 | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | MMT-8: Week 25 | 10.8 score on a scale | Standard Deviation 16.71 |
| IgPro20 | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-PGDA: Week 25 | -21.2 score on a scale | Standard Deviation 19.86 |
| IgPro20 | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-EGA: Week 25 | -17.4 score on a scale | Standard Deviation 22.54 |
| IgPro20 | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | PGA: Week 25 | -13.0 score on a scale | Standard Deviation 26.52 |
| IgPro20 | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | HAQ - DI: Week 25 | -0.195 score on a scale | Standard Deviation 0.4627 |
| IgPro20 | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | CDASI-A: Week 25 | -11.5 score on a scale | Standard Deviation 10.85 |
| Placebo | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | HAQ - DI: Week 25 | -0.172 score on a scale | Standard Deviation 0.4801 |
| Placebo | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | MMT-8: Week 25 | 15.2 score on a scale | Standard Deviation 24.02 |
| Placebo | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | PGA: Week 25 | -16.8 score on a scale | Standard Deviation 20.57 |
| Placebo | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-PGDA: Week 25 | -21.8 score on a scale | Standard Deviation 18.64 |
| Placebo | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | CDASI-A: Week 25 | -7.9 score on a scale | Standard Deviation 8.91 |
| Placebo | Mean Changes From Baseline in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-EGA: Week 25 | -13.9 score on a scale | Standard Deviation 17.67 |
Secondary
Mean Changes From Baseline in MMT-8
The MMT-8 was a set of 8 designated muscles which were tested bilaterally (potential score ranging from 0 to 150): 7 biaxial muscles with a potential score 0 to 140 and 1 axial (neck flexors) with a potential score of 0 to 10. Improvement is documented with an increase in score. LS means were estimated using a MMRM including treatment, visit, the interaction between treatment and visit, and region as fixed effects, baseline MMT-8 as a continuous covariate and participant as a random effect.
Time frame: From Baseline to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| IgPro20 | Mean Changes From Baseline in MMT-8 | 8.9 score on a scale |
| Placebo | Mean Changes From Baseline in MMT-8 | 11.3 score on a scale |
p-value: 0.73099495% CI: [-10.15, 5.33]MMRM
Secondary
Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI
Individual CSMs included following: MDAAT-PGDA, PGA assessment, MMT-8, HAQ-DI, and MDAAT extramacular global assessment. Higher values were associated with a better state of health for the MMT-8 (range 0 -150) assessment, while lower values were associated with a better state of health for: MDAAT-PGDA (range 0 -100), PGA (range 0-100), HAQ-DI (range 0-3), MDAAT-EGA (range 0 -100), and CDASI-A (range 0-100).
Time frame: From Week 25 to Week 53
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IgPro20 | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-PGDA: Week 53 | -8.5 score on a scale | Standard Deviation 17.13 |
| IgPro20 | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | HAQ - DI: Week 53 | -0.106 score on a scale | Standard Deviation 0.2587 |
| IgPro20 | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | MMT-8: Week 53 | 7.1 score on a scale | Standard Deviation 11.32 |
| IgPro20 | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-EGA: Week 53 | -0.9 score on a scale | Standard Deviation 12.38 |
| IgPro20 | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | PGA: Week 53 | -3.3 score on a scale | Standard Deviation 20.94 |
| IgPro20 | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | CDASI-A: Week 53 | -0.8 score on a scale | Standard Deviation 7.52 |
| Placebo | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-PGDA: Week 53 | -15.5 score on a scale | Standard Deviation 18.74 |
| Placebo | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | PGA: Week 53 | -9.0 score on a scale | Standard Deviation 23.87 |
| Placebo | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | HAQ - DI: Week 53 | -0.162 score on a scale | Standard Deviation 0.4477 |
| Placebo | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | CDASI-A: Week 53 | -5.3 score on a scale | Standard Deviation 9.7 |
| Placebo | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | MDAAT-EGA: Week 53 | -11.5 score on a scale | Standard Deviation 18.21 |
| Placebo | Mean Changes From Week 25 in Individual CSMs (Except Muscle Enzymes) and CDASI | MMT-8: Week 53 | 7.9 score on a scale | Standard Deviation 13.44 |
Secondary
Mean TIS
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100; higher the score, better the condition), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points, respectively on the TIS. Least squares (LS) means were estimated using a mixed model repeated measures (MMRM) including treatment, visit, the interaction between treatment and visit, region, and baseline MMT-8 (\<=142 points vs \>142 points) as fixed effects, participant as a random effect.
Time frame: At Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| IgPro20 | Mean TIS | 32.24 score on a scale |
| Placebo | Mean TIS | 30.78 score on a scale |
p-value: 0.36093995% CI: [-6.651, 9.57]MMRM
Secondary
Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Time frame: From Baseline to Week 13 and 25
Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Self-Care: More than 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Usual Activities: More than 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Mobility: At least 1 level improvement | 10 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Usual Activities: At least 1 level improvement | 16 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Mobility: At least 2 level improvement | 5 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Self-Care: More than 2 level improvement | 2 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Mobility: More than 2 level improvement | 0 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Mobility: More than 2 level improvement | 0 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Self-Care: At least 1 level improvement | 9 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Mobility: At least 1 level improvement | 16 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Self-Care: At least 2 level improvement | 2 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Usual Activities: At least 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Usual Activities: At least 1 level improvement | 15 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Mobility: At least 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Usual Activities: At least 2 level improvement | 2 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Self-Care: At least 1 level improvement | 15 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Usual Activities: More than 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Self-Care: At least 2 level improvement | 2 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Usual Activities: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Mobility: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Self-Care: At least 1 level improvement | 13 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Self-Care: At least 2 level improvement | 2 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Self-Care: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Usual Activities: At least 1 level improvement | 15 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Self-Care: At least 2 level improvement | 3 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Self-Care: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Mobility: At least 1 level improvement | 15 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Usual Activities: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Mobility: At least 1 level improvement | 14 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Mobility: At least 2 level improvement | 3 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Mobility: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Self-Care: At least 1 level improvement | 15 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Usual Activities: At least 2 level improvement | 3 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Usual Activities: At least 1 level improvement | 13 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 25: Usual Activities: At least 2 level improvement | 1 Participants |
| Placebo | Number of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L) | Week 13: Mobility: At least 2 level improvement | 0 Participants |
Secondary
Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Time frame: From Week 25 to 41 and 53
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: More than 2 level improvement | 0 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 2 level improvement | 3 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 1 level improvement | 10 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: No Reduction | 29 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 1 level improvement | 10 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: More than 2 level improvement | 0 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: No Reduction | 32 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 1 level improvement | 5 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: More than 2 level improvement | 0 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: No Reduction | 23 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 1 level improvement | 13 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: More than 2 level improvement | 1 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: No Reduction | 24 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 1 level improvement | 8 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 2 level improvement | 2 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 2 level improvement | 3 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: More than 2 level improvement | 0 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: No Reduction | 33 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 1 level improvement | 2 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 2 level improvement | 2 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: More than 2 level improvement | 0 Participants |
| IgPro20 | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: No Reduction | 21 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 1 level improvement | 11 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: More than 2 level improvement | 1 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 2 level improvement | 1 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: No Reduction | 25 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: No Reduction | 28 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 1 level improvement | 7 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: No Reduction | 23 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: More than 2 level improvement | 1 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: No Reduction | 31 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 1 level improvement | 10 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 1 level improvement | 9 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 2 level improvement | 1 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: No Reduction | 22 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 2 level improvement | 2 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: No Reduction | 31 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 1 level improvement | 8 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 1 level improvement | 10 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: More than 2 level improvement | 0 Participants |
| Placebo | Number of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 2 level improvement | 1 Participants |
Secondary
Number of Participants Meeting DOW and Receiving Rescue Steroid Treatment
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The Number of participants meeting DOW and who received rescue steroid treatment are reported here.
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IgPro20 | Number of Participants Meeting DOW and Receiving Rescue Steroid Treatment | 0 Participants |
| Placebo | Number of Participants Meeting DOW and Receiving Rescue Steroid Treatment | 2 Participants |
Secondary
Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Time frame: Up to Week 25 and 52
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = all participants with oral concomitant corticosteroid treatment at Week 1 who were part of mITT Ex.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IgPro20 | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 25% | 16 Participants |
| IgPro20 | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 50% | 11 Participants |
| IgPro20 | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 75% | 3 Participants |
| IgPro20 | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 25% | 19 Participants |
| IgPro20 | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 50% | 17 Participants |
| IgPro20 | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 75% | 12 Participants |
| Placebo | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 50% | 14 Participants |
| Placebo | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 25% | 14 Participants |
| Placebo | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 25% | 17 Participants |
| Placebo | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 50% | 8 Participants |
| Placebo | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 75% | 9 Participants |
| Placebo | Number of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 75% | 3 Participants |
Secondary
Number of Participants Who Start Oral Corticosteroid Dose Taper
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT. Here, overall number of participants analyzed (N) = participants with oral concomitant corticosteroid treatment at Week 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IgPro20 | Number of Participants Who Start Oral Corticosteroid Dose Taper | 19 Participants |
| Placebo | Number of Participants Who Start Oral Corticosteroid Dose Taper | 19 Participants |
Secondary
Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Time frame: From Baseline to Week 13 and 25
Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Usual Activities : More than 2 level improvement | 1.8 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Self-Care : More than 2 level improvement | 1.9 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Usual Activities : At least 1 level improvement | 28.1 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Usual Activities : At least 1 level improvement | 15.8 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Usual Activities : At least 2 level improvement | 5.3 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Mobility : At least 1 level improvement | 19.2 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Usual Activities : More than 2 level improvement | 3.5 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Mobility : At least 2 level improvement | 9.6 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Mobility : At least 1 level improvement | 28.1 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Usual Activities : At least 2 level improvement | 1.8 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Mobility : At least 2 level improvement | 1.8 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Mobility : More than 2 level improvement | 0 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Mobility : More than 2 level improvement | 0 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Self-Care : At least 1 level improvement | 3.8 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Self-Care : At least 1 level improvement | 26.3 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Self-Care : At least 2 level improvement | 1.9 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Self-Care : At least 2 level improvement | 3.5 percentage of participants |
| IgPro20 | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Self-Care : More than 2 level improvement | 1.8 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Self-Care : At least 2 level improvement | 3.6 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Self-Care : More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Mobility : At least 1 level improvement | 29.2 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Self-Care : At least 1 level improvement | 31.3 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Usual Activities : At least 1 level improvement | 29.3 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Usual Activities : At least 1 level improvement | 27.3 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Usual Activities : At least 2 level improvement | 5.5 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Usual Activities : More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Mobility : At least 2 level improvement | 6.3 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Mobility : More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Self-Care : At least 2 level improvement | 6.3 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Self-Care : More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Usual Activities : At least 2 level improvement | 5.2 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 25: Usual Activities : More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Mobility : At least 1 level improvement | 27.3 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Mobility : At least 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Mobility : More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 13: Self-Care : At least 1 level improvement | 23.6 percentage of participants |
Secondary
Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L
EQ-5D-5L was assessed across 5 levels, with participants selecting the option that best described their health on that day, ranging from no problems to unable to walk, wash/dress, or perform usual activities. Out of total participants of each arm, only participants having no reduction, at least 1 Level, 2 Levels, and more than 2 Levels of improvement from baseline in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L are reported in this outcome measure.
Time frame: From Week 25 to 41 and 53
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: No Reduction | 52.5 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 2 level improvement | 2.1 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: No Reduction | 68.1 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 1 level improvement | 21.3 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: More than 2 level improvement | 2.1 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 1 level improvement | 0.6 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: No Reduction | 60.0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: More than 2 level improvement | 0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 1 level improvement | 20.0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: More than 2 level improvement | 0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 2 level improvement | 6.4 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: No Reduction | 82.5 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 2 level improvement | 2.1 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 2 level improvement | 5.0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 1 level improvement | 25.0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 1 level improvement | 5.0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: More than 2 level improvement | 0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 2 level improvement | 5.0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: No Reduction | 61.7 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: No Reduction | 48.9 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 2 level improvement | 7.5 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: More than 2 level improvement | 0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: More than 2 level improvement | 0 percentage of participants |
| IgPro20 | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 1 level improvement | 27.7 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 1 level improvement | 22.2 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: No Reduction | 59.5 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: No Reduction | 62.2 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 1 level improvement | 17.8 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: At least 2 level improvement | 2.2 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Mobility: More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: No Reduction | 20.0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 1 level improvement | 20.0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: At least 2 level improvement | 2.2 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Self-Care: More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: No Reduction | 68.9 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: No Reduction | 67.6 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: At least 2 level improvement | 2.2 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 41: Usual Activities: More than 2 level improvement | 0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: More than 2 level improvement | 2.7 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Mobility: At least 1 level improvement | 18.9 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: No Reduction | 62.2 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 1 level improvement | 29.7 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Self-Care: At least 2 level improvement | 2.7 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 1 level improvement | 27.0 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: At least 2 level improvement | 5.4 percentage of participants |
| Placebo | Percentage of Participants Having no Reduction in Levels, at Least 1 Level, 2 Levels, and More Than 2 Levels of Improvement From Week 25 in Mobility, Self-care, and Usual Activities Domains of EQ-5D-5L | Week 53: Usual Activities: More than 2 level improvement | 0 percentage of participants |
Secondary
Percentage of Participants Meeting DOW and Receiving Rescue Steroid Treatment
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The percentage of participants meeting DOW and who received rescue steroid treatment are reported here.
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 | Percentage of Participants Meeting DOW and Receiving Rescue Steroid Treatment | 0 percentage of participants |
| Placebo | Percentage of Participants Meeting DOW and Receiving Rescue Steroid Treatment | 3.1 percentage of participants |
Secondary
Percentage of Participants Receiving Rescue Corticosteroid Treatment
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 | Percentage of Participants Receiving Rescue Corticosteroid Treatment | 1.5 percentage of participants |
| Placebo | Percentage of Participants Receiving Rescue Corticosteroid Treatment | 9.2 percentage of participants |
Secondary
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%
Reduction in corticosteroid dose.
Time frame: At Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25% | 23.2 percentage of participants |
| Placebo | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25% | 20.2 percentage of participants |
p-value: 0.33534795% CI: [0.52, 2.766]Regression, Logistic
Secondary
Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75%
Time frame: Up to Week 25 and 52
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = all participants with oral concomitant corticosteroid treatment at Week 1 who were part of mITT Ex.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 25% | 40.0 percentage of participants |
| IgPro20 | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 50% | 27.5 percentage of participants |
| IgPro20 | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 75% | 7.5 percentage of participants |
| IgPro20 | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 25% | 47.5 percentage of participants |
| IgPro20 | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 50% | 42.5 percentage of participants |
| IgPro20 | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 75% | 30.0 percentage of participants |
| Placebo | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 50% | 35.9 percentage of participants |
| Placebo | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 25% | 35.9 percentage of participants |
| Placebo | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 25% | 43.6 percentage of participants |
| Placebo | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 50% | 20.5 percentage of participants |
| Placebo | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 52: Reduction >= 75% | 23.1 percentage of participants |
| Placebo | Percentage of Participants Who Are Able to Reduce the Oral Corticosteroid Dose by >= 25%, >= 50%, >= 75% | Week 25: Reduction >= 75% | 7.7 percentage of participants |
Secondary
Percentage of Participants Whose Rescue Corticosteroid Treatment is Tapered
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT. Here, overall number of participants analyzed (N) = participants receiving oral rescue corticosteroid treatment up to Week 25.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 | Percentage of Participants Whose Rescue Corticosteroid Treatment is Tapered | 0 percentage of participants |
| Placebo | Percentage of Participants Whose Rescue Corticosteroid Treatment is Tapered | 100.0 percentage of participants |
Secondary
Percentage of Participants Who Start Oral Corticosteroid Dose Taper
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT. Here, overall number of participants analyzed (N) = participants with oral concomitant corticosteroid treatment at Week 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 | Percentage of Participants Who Start Oral Corticosteroid Dose Taper | 41.3 percentage of participants |
| Placebo | Percentage of Participants Who Start Oral Corticosteroid Dose Taper | 39.6 percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs
Time frame: Up to 5 years
Population: Period 1: Safety analysis set (SAF): All randomized participants who received any IMP, analyzed by actual treatment. Period 2: SAF extended (SAF-EX): Participants from SAF who completed 24 weeks in Period 1 and received any IMP in Period 2. Period 3: SAF for SP3 (SAF-P3): Participants from SAF-EX who completed 52 weeks in Periods 1 and 2 and received any IMP after Week 52.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | TEAEs | 82.1 percentage of participants |
| IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Serious TEAEs | 4.5 percentage of participants |
| IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Related TEAEs | 52.2 percentage of participants |
| Placebo | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Related TEAEs | 25.4 percentage of participants |
| Placebo | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | TEAEs | 67.2 percentage of participants |
| Placebo | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Serious TEAEs | 7.5 percentage of participants |
| Period 2 Sequence A: IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | TEAEs | 69.6 percentage of participants |
| Period 2 Sequence A: IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Related TEAEs | 17.9 percentage of participants |
| Period 2 Sequence A: IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Serious TEAEs | 3.6 percentage of participants |
| Period 2 Sequence B: Placebo / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Serious TEAEs | 5.5 percentage of participants |
| Period 2 Sequence B: Placebo / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Related TEAEs | 43.6 percentage of participants |
| Period 2 Sequence B: Placebo / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | TEAEs | 74.5 percentage of participants |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | TEAEs | 75.0 percentage of participants |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Serious TEAEs | 13.9 percentage of participants |
| Period 3 Sequence A: IgPro20/ IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Related TEAEs | 13.9 percentage of participants |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | TEAEs | 76.5 percentage of participants |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Related TEAEs | 20.6 percentage of participants |
| Period 3 Sequence B: Placebo / IgPro20 / IgPro20 | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Related TEAEs and Serious TEAEs | Serious TEAEs | 20.6 percentage of participants |
Secondary
Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS
The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.
Time frame: Up to Week 53
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IgPro20 | Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS | TIS >= 20 Points | 31.0 days |
| IgPro20 | Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS | TIS >= 40 Points | 112.0 days |
| IgPro20 | Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS | TIS >= 60 Points | 308.0 days |
| Placebo | Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS | TIS >= 40 Points | 137.0 days |
| Placebo | Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS | TIS >= 20 Points | 32.0 days |
| Placebo | Period 1 and 2: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points Improvement on the TIS | TIS >= 60 Points | 336.0 days |
Secondary
Period 1: Mean TIS at Each Visit
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points on the TIS.
Time frame: At Week 5, 9, 13, 17, 21, and 25
Population: Analysis was performed on the mITT analysis set. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IgPro20 | Period 1: Mean TIS at Each Visit | Week 5 | 23.22 score on a scale | Standard Deviation 16.387 |
| IgPro20 | Period 1: Mean TIS at Each Visit | Week 9 | 32.54 score on a scale | Standard Deviation 18.132 |
| IgPro20 | Period 1: Mean TIS at Each Visit | Week 13 | 37.68 score on a scale | Standard Deviation 17.267 |
| IgPro20 | Period 1: Mean TIS at Each Visit | Week 17 | 41.00 score on a scale | Standard Deviation 16.926 |
| IgPro20 | Period 1: Mean TIS at Each Visit | Week 21 | 43.56 score on a scale | Standard Deviation 17.112 |
| IgPro20 | Period 1: Mean TIS at Each Visit | Week 25 | 40.20 score on a scale | Standard Deviation 20.093 |
| Placebo | Period 1: Mean TIS at Each Visit | Week 21 | 36.67 score on a scale | Standard Deviation 21.882 |
| Placebo | Period 1: Mean TIS at Each Visit | Week 5 | 20.97 score on a scale | Standard Deviation 16.684 |
| Placebo | Period 1: Mean TIS at Each Visit | Week 17 | 35.44 score on a scale | Standard Deviation 21.458 |
| Placebo | Period 1: Mean TIS at Each Visit | Week 9 | 26.67 score on a scale | Standard Deviation 17.924 |
| Placebo | Period 1: Mean TIS at Each Visit | Week 25 | 40.21 score on a scale | Standard Deviation 21.812 |
| Placebo | Period 1: Mean TIS at Each Visit | Week 13 | 31.68 score on a scale | Standard Deviation 20.705 |
Secondary
Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment Visual Analog Scale (VAS) worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IgPro20 | Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice | More Than Twice | 0 Participants |
| IgPro20 | Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice | At Least Once | 2 Participants |
| IgPro20 | Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice | At Least Twice | 0 Participants |
| Placebo | Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice | More Than Twice | 0 Participants |
| Placebo | Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice | At Least Once | 3 Participants |
| Placebo | Period 1: Number of Participants Meeting Definition of Worsening (DOW) at Least Once, Twice, or > Twice | At Least Twice | 0 Participants |
Secondary
Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Participants were considered and reported in more than one category (TIS \>= 20, \>= 40 and \>= 60 Points).
Time frame: At Week 5, 9, 13, 17, 21, and 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 5: TIS >= 20 Points | 47.7 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 5: TIS >= 40 Points | 16.9 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 5: TIS >= 60 Points | 1.5 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 9: TIS >= 20 Points | 63.1 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 9: TIS >= 40 Points | 32.3 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 9: TIS >= 60 Points | 9.2 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 13: TIS >= 20 Points | 73.8 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 13: TIS >= 40 Points | 36.9 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 13: TIS >= 60 Points | 13.8 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 17: TIS >= 20 Points | 75.4 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 17: TIS >= 40 Points | 44.6 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 17: TIS >= 60 Points | 15.4 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 21: TIS >= 20 Points | 73.4 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 21: TIS >= 40 Points | 53.1 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 21: TIS >= 60 Points | 18.8 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 20 Points | 64.1 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 40 Points | 45.3 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 60 Points | 17.2 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 21: TIS >= 40 Points | 33.3 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 5: TIS >= 20 Points | 47.7 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 17: TIS >= 20 Points | 57.8 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 5: TIS >= 40 Points | 15.4 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 60 Points | 15.9 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 5: TIS >= 60 Points | 1.5 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 17: TIS >= 40 Points | 34.4 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 9: TIS >= 20 Points | 56.3 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 21: TIS >= 60 Points | 12.7 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 9: TIS >= 40 Points | 26.6 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 17: TIS >= 60 Points | 15.6 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 9: TIS >= 60 Points | 4.7 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 40 Points | 39.7 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 13: TIS >= 20 Points | 60.9 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 21: TIS >= 20 Points | 60.3 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 13: TIS >= 40 Points | 31.3 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 20 Points | 65.1 percentage of participants |
| Placebo | Period 1: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 13: TIS >= 60 Points | 10.9 percentage of participants |
Secondary
Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Once | 3.1 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Twice | 0 percentage of participants |
| IgPro20 | Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | More Than Twice | 0 percentage of participants |
| Placebo | Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Once | 4.6 percentage of participants |
| Placebo | Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Twice | 0 percentage of participants |
| Placebo | Period 1: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | More Than Twice | 0 percentage of participants |
Secondary
Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS
The observation was censored if no improvement was observed before the intake of rescue/increased doses of oral corticosteroids in SP1 or before the end of the period.
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IgPro20 | Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS | TIS >= 60 Points | NA days |
| IgPro20 | Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS | TIS >= 20 Points | 31.0 days |
| IgPro20 | Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS | TIS >= 40 Points | 112.0 days |
| Placebo | Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS | TIS >= 60 Points | NA days |
| Placebo | Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS | TIS >= 20 Points | 32.0 days |
| Placebo | Period 1: Time to First Achieving TIS >= 20, >= 40, and >= 60 Points on the TIS | TIS >= 40 Points | 112.0 days |
Secondary
Period 2: Mean TIS at Each Visit
The TIS was a sum response criterion which incorporates 6 weighted IMACS CSMs including Physician and PGA, MMT-8, Health Assessment Questionnaire, Muscle Enzyme, and EGA. A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were \>= 20, \>= 40, and \>= 60 points on the TIS.
Time frame: Week 25, 29, 33, 37, 41, 45, 49, and 53
Population: Analysis was performed on the mITT analysis set extended (mITT-Ex) that comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex. Here, overall number of participants analyzed (N) = participants evaluable for this outcome measure, and number analyzed (n) = participants with evaluable data for each specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 25 | 40.09 score on a scale | Standard Deviation 19.547 |
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 29 | 45.05 score on a scale | Standard Deviation 19.931 |
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 33 | 44.66 score on a scale | Standard Deviation 19.346 |
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 37 | 47.81 score on a scale | Standard Deviation 18.805 |
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 41 | 50.49 score on a scale | Standard Deviation 18.255 |
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 45 | 50.89 score on a scale | Standard Deviation 19.018 |
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 49 | 51.63 score on a scale | Standard Deviation 17.844 |
| IgPro20 | Period 2: Mean TIS at Each Visit | Week 53 | 50.32 score on a scale | Standard Deviation 15.886 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 53 | 54.26 score on a scale | Standard Deviation 15.022 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 25 | 38.08 score on a scale | Standard Deviation 22.658 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 41 | 51.68 score on a scale | Standard Deviation 15.943 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 29 | 42.74 score on a scale | Standard Deviation 20.057 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 49 | 50.51 score on a scale | Standard Deviation 16.01 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 33 | 46.23 score on a scale | Standard Deviation 18.258 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 45 | 52.94 score on a scale | Standard Deviation 15.078 |
| Placebo | Period 2: Mean TIS at Each Visit | Week 37 | 48.49 score on a scale | Standard Deviation 17.071 |
Secondary
Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Time frame: From Week 25 up to Week 53
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IgPro20 | Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Once | 2 Participants |
| IgPro20 | Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Twice | 0 Participants |
| IgPro20 | Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice | More Than Twice | 0 Participants |
| Placebo | Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Once | 1 Participants |
| Placebo | Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Twice | 0 Participants |
| Placebo | Period 2: Number of Participants Meeting DOW at Least Once, Twice, or > Twice | More Than Twice | 0 Participants |
Secondary
Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points
Participants were considered and reported in more than one category (TIS \>= 20, \>= 40 and \>= 60 Points).
Time frame: Week 25, 29, 33, 37, 41, 45, 49, and 53
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 33: TIS >= 20 Points | 85.2 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 40 Points | 56.4 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 60 Points | 20.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 29: TIS >= 20 Points | 87.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 29: TIS >= 40 Points | 64.8 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 29: TIS >= 60 Points | 31.5 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 20 Points | 80.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 33: TIS >= 40 Points | 57.4 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 33: TIS >= 60 Points | 22.2 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 37: TIS >= 20 Points | 82.7 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 37: TIS >= 40 Points | 57.7 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 37: TIS >= 60 Points | 28.8 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 41: TIS >= 20 Points | 84.3 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 41: TIS >= 40 Points | 64.7 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 41: TIS >= 60 Points | 37.3 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 45: TIS >= 20 Points | 80.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 45: TIS >= 40 Points | 64.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 45: TIS >= 60 Points | 40.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 49: TIS >= 20 Points | 80.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 49: TIS >= 40 Points | 68.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 49: TIS >= 60 Points | 36.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 53: TIS >= 20 Points | 78.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 53: TIS >= 40 Points | 56.0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 53: TIS >= 60 Points | 30.0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 53: TIS >= 40 Points | 66.0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 20 Points | 77.8 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 41: TIS >= 20 Points | 84.6 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 40 Points | 48.1 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 49: TIS >= 20 Points | 70.0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 25: TIS >= 60 Points | 18.5 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 41: TIS >= 40 Points | 73.1 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 29: TIS >= 20 Points | 84.9 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 53: TIS >= 20 Points | 72.0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 29: TIS >= 40 Points | 54.7 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 41: TIS >= 60 Points | 30.8 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 29: TIS >= 60 Points | 22.6 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 49: TIS >= 40 Points | 58.0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 33: TIS >= 20 Points | 90.6 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 45: TIS >= 20 Points | 84.3 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 33: TIS >= 40 Points | 64.2 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 53: TIS >= 60 Points | 24.0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 33: TIS >= 60 Points | 24.5 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 45: TIS >= 40 Points | 66.7 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 37: TIS >= 20 Points | 88.5 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 49: TIS >= 60 Points | 22.0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 37: TIS >= 40 Points | 67.3 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 45: TIS >= 60 Points | 31.4 percentage of participants |
| Placebo | Period 2: Percentage of Participants Achieving TIS ≥ 20, ≥ 40 and ≥ 60 Points | Week 37: TIS >= 60 Points | 25.0 percentage of participants |
Secondary
Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.)
Time frame: From Week 25 up to Week 53
Population: Analysis was performed on the mITT-Ex analysis set. The mITT-Ex comprised all participants in mITT who completed the first 24 weeks of SP1 and received any amount of the IMP in SP2. The documented failure to take any amount of randomized IMP in SP2 led to the exclusion of the participant from mITT-Ex.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 | Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Once | 3.6 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Twice | 0 percentage of participants |
| IgPro20 | Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | More Than Twice | 0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Once | 1.9 percentage of participants |
| Placebo | Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | At Least Twice | 0 percentage of participants |
| Placebo | Period 2: Percentage of Participants Meeting DOW at Least Once, Twice, or > Twice | More Than Twice | 0 percentage of participants |
Secondary
Time to First Intake of Rescue Corticosteroid Treatment
The observation was censored if no Rescue was observed before the last day of the last week with IMP intake or before the end of the period.
Time frame: Up to Week 25
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IgPro20 | Time to First Intake of Rescue Corticosteroid Treatment | NA days |
| Placebo | Time to First Intake of Rescue Corticosteroid Treatment | NA days |
Secondary
Time to Meeting DOW for the First Time
The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart: PGA Assessment VAS worsening \>= 2 cm\* and MMT-8 worsening \>= absolute 10%, or EGA worsening \>= 2 cm on the MDAAT VAS, or Any 3 of 6 CSM worsening by \>= absolute 20%. (\*If baseline PGA VAS is 8 to 10, then any worsening on Physician Global VAS was acceptable as long as MMT-8 criterion was met.) The observation was censored if no DOW was observed before the intake of rescue treatment or before the end of the period.
Time frame: Up to Week 53
Population: Analysis was performed on the mITT analysis set. The mITT analysis set comprises all participants who underwent study screening procedures and were randomized to receive any amount of randomized IMP. The documented failure to take any amount of randomized IMP, or the lack of any post-randomization efficacy data, led to the exclusion of the participant from the mITT.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IgPro20 | Time to Meeting DOW for the First Time | NA days |
| Placebo | Time to Meeting DOW for the First Time | NA days |