Systemic Lupus Erythematosus
Conditions
Keywords
Lupus, Systemic Lupus, SLE
Brief summary
The purpose of this study is to determine whether CC-220 is effective for the treatment of skin, joint and serological manifestations of systemic lupus erythematosus.
Detailed description
The study consists of 2 parts. Part 1 is a randomized, double-blind, placebo controlled, ascending dose study to evaluate the safety and tolerability of CC-220 in SLE subjects. Subject participation in Part 1 consists of 3 phases: * Pre-treatment Screening Phase: up to 28 days prior to the first dose of the investigational product (IP) * Treatment Phase: up to 84 days * Observation Phase: 84 day post-treatment A total of approximately 40 subjects will be randomized into 4 dose groups with a 4:1 ratio of CC-220 (0.3 mg every other day \[QOD\], 0.3 mg everyday \[QD\], 0.6 mg and 0.3 mg on alternating days, and 0.6 mg QD) or matching placebo. In each dosing arm, 8 subjects will receive active drug and 2 subjects will receive placebo. The Treatment Phase will be up to 84 days in duration for all dose groups. Subjects who discontinue IP early and all subjects who complete the 84 day treatment phase will enter into the Observational Follow-up Phase for an 84 day period. A subject will be permitted to reduce their dose one time during Part 1 of the study. Part 2 is the Active Treatment Extension Phase (ATEP) which is an extension to evaluate the long-term efficacy and safety/tolerability of CC-220 in SLE subjects who completed Part 1 of the study. Subjects who complete the Treatment Phase of Part 1 of the study will be eligible to receive CC-220 in the ATEP for up to 2 years. All subjects who participate in the ATEP will receive either 0.3 mg QD or 0.6 mg and 0.3 mg QD on alternating days. Subjects who terminate the Treatment Phase of Part 1 early will not be eligible for entry into the ATEP. Subject participation consists of two phases: * Active Treatment Extension Phase: Up to 2 years * Observational Follow-up Phase: One month
Interventions
DRUGCC-220
0.3 mg oral capsules once every other day with or without food
DRUGPlacebo
Matching oral placebo daily
Sponsors
Celgene
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
Part 1 * The subject has an established diagnosis of systemic lupus erythematosus (SLE) as defined by the 1997 Update of the 1982 ACR Revised Criteria for Classification of SLE at screening. The diagnosis is fulfilled provided that at least 4 criteria are met. * Disease history of SLE ≥ 6 months at baseline * Females of childbearing potential (FCBP) must: * Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence from heterosexual contact. * Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. * Male subjects must: * Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy. * If the subject is using oral corticosteroids, the daily dose must be less than or equal to 10 mg of prednisone or equivalent during the study; the dose must be stable over the 4 weeks preceding screening and throughout the study. * All subjects taking hydroxychloroquine, chloroquine and/or quinacrine during the study must have documentation of a normal ophthalmologic examination performed within 1 year of the Baseline Visit. * For subjects not taking corticosteroids, or antimalarials, the last dose (in case of previous use) must be at least 4 weeks prior to screening. ATEP * Male or female 18 years of age or older * Understand and voluntarily sign an ICD prior to the initiation of any study related assessments/procedures * Able to adhere to the study visit schedule and other protocol requirements. Pregnancy * Females of childbearing potential (FCBP) must: * Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence\* from heterosexual contact. * Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. * Male subjects must: \- Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception.) * Male subjects must agree not to donate semen or sperm during therapy and for at least 90 days following the discontinuation of IP. * All subjects must: * Understand that the IP could have potential teratogenic risk * Agree to abstain from donating blood while taking IP and for 28 days following discontinuation of the IP * Agree not to share IP with another person * Other than the subject, FCBP and males able to father a child should not handle the IP or touch the capsules unless gloves are worn * Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan. Concomitant Medications * If the subject is using oral corticosteroids, the daily dose must be less than or equal to 10 mg of prednisone or equivalent during the study; the dose must be stable over the 4 weeks preceding randomization and throughout the study. * All subjects taking hydroxychloroquine, chloroquine or quinacrine during the study must have documentation of a normal ophthalmologic examination performed within 1 year of the Baseline Visit. * For subjects not taking corticosteroids the last dose (in case of previous use) must be at least 4 weeks prior to screening.
Exclusion criteria
* The subject has been treated with intra-articular, intramuscular or IV pulse corticosteroids within 4 weeks of screening. * The subject has received high dose oral prednisone (\> 100 mg/day) within 4 weeks of screening. * The subject has received cyclophosphamide, azathioprine or mycophenolate mofetil within 12 weeks of screening. * The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 pharmacokinetic half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to screening; OR participation in two or more investigational drug trials within 12 months of screening. * Unstable lupus nephritis defined as: proteinuria \> 1.0 g/24 hour /1.73 m2 OR eGFR of less than 60 mL/1.73 m2 CNS disease, including active severe CNS lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), cerebritis or CNS vasculitis) requiring therapeutic intervention within 6 months of screening. * The subject has New York Heart Association (NYHA) Class III or IV congestive heart failure. * Presence of hepatitis B surface antigen (HBsAG). Subjects may have a positive anti-hepatitis B core antibody (anti-HBc) if the anti-hepatitis B surface antibody (anti-HBs) is positive as well. * Antibodies to hepatitis C at Screening. * The subject has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease or acquired immune deficiency syndrome (AIDs). * Has a history of an organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. * Malignancy or history of malignancy, except for: * treated (ie, cured) basal cell or squamous cell in situ skin carcinomas; * treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of Screening * Systemic bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 2 weeks prior to Screening and no new or recurrent infections prior to the Baseline visit. * History of venous thrombosis or any thromboembolic events within 2 years of screening. * Clinical evidence of significant unstable or uncontrolled acute or chronic disease not due to SLE (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, psychiatric or infectious disease) which in the opinion of the investigator could put the subject at undue risk or confound study results. * Presence of active uveitis or any other clinically significant ophthalmological finding. * History or current diagnosis of peripheral or radicular neuropathy. Any clinically significant abnormalities on ECG, which, in the opinion of the investigator would interfere with safe participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts. | A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts. | A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Concentration (Tmax) of Iberdomide | Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. | Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed. |
| Terminal Phase Half-Life (T1/2) Of Iberdomide | Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. | Terminal phase half-life in plasma, calculated as \[(In 2)/λz\]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed. |
| Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity. |
| Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity. |
| Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count. |
| Change From Baseline in Tender Joint Count During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count. |
| Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. | The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed. |
| Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: * 0 = none * 1 = mild disease * 2 = moderate disease * 3 = severe disease |
| Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero). |
| Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately. |
| Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an X representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement. |
| Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity. |
| Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity. |
| Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP. | The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity. |
| Maximum Observed Concentration (Cmax) Of Iberdomide | Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP. | Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed. |
Countries
United States
Participant flow
Recruitment details
The multi-center study was conducted in the United States. Forty-two participants were enrolled at 11 study sites.
Pre-assignment details
In part 1 of the study, participants were randomly assigned to 1 of 4 dose cohorts; within each cohort participants were randomized in a 4:1 ratio to receive iberdomide or placebo. Participants who completed the Part 1 treatment phase were eligible to receive iberdomide for up to 2 years in the active treatment extension phase (ATEP).
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Placebo Participants received identically matching placebo capsules for up to 84 days during the Part 1 treatment phase. | 8 |
| Part 1: Iberdomide 0.3 mg QOD Participants received iberdomide 0.3 mg capsules every other day (QOD) for up to 84 days during Part 1 treatment phase. | 8 |
| Part 1: Iberdomide 0.3 mg QD Participants received 0.3 mg iberdomide capsules QD up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules QD during ATEP up to 2 years. | 8 |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days Participants received iberdomide 0.6 mg capsules on alternating (ALT) days with 0.3 mg iberdomide capsules on alternating days up to 84 days during the Part 1 treatment phase and remained on their assigned dose of 0.3 mg iberdomide capsules ALT days with 0.6 mg capsules ALT days during the ATEP up to 2 years. | 9 |
| Part 1: Iberdomide 0.6 mg QD Participants received 0.6 mg iberdomide capsules QD for up to 84 days during Part 1 treatment phase. | 9 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Active Treatment Extension Phase | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 4 |
| Active Treatment Extension Phase | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Active Treatment Extension Phase | Miscellaneous | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Active Treatment Extension Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Part 1 Treatment Phase | Adverse Event | 1 | 0 | 0 | 2 | 3 | 0 | 0 |
| Part 1 Treatment Phase | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part 1 Treatment Phase | Miscellaneous | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Part 1 Treatment Phase | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: Iberdomide 0.3 mg QOD | Total | Part 1: Iberdomide 0.6 mg QD | Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Part 1: Placebo | Part 1: Iberdomide 0.3 mg QD |
|---|---|---|---|---|---|---|
| Age, Continuous | 46.0 Years STANDARD_DEVIATION 8.62 | 47.2 Years STANDARD_DEVIATION 10.6 | 47.2 Years STANDARD_DEVIATION 13.56 | 49.8 Years STANDARD_DEVIATION 13.07 | 44.8 Years STANDARD_DEVIATION 6.58 | 48.0 Years STANDARD_DEVIATION 10.85 |
| Baseline Swollen Joint Count | 5.2 Swollen Joints STANDARD_DEVIATION 2.28 | 5.5 Swollen Joints STANDARD_DEVIATION 3.11 | 4.0 Swollen Joints STANDARD_DEVIATION 1.15 | 6.3 Swollen Joints STANDARD_DEVIATION 2.49 | 4.0 Swollen Joints STANDARD_DEVIATION 2.12 | 7.0 Swollen Joints STANDARD_DEVIATION 5.22 |
| Baseline Tender Joint Count | 7.3 Joints STANDARD_DEVIATION 4.97 | 12.7 Joints STANDARD_DEVIATION 8.9 | 13.3 Joints STANDARD_DEVIATION 11.29 | 16.9 Joints STANDARD_DEVIATION 9.09 | 10.0 Joints STANDARD_DEVIATION 7.21 | 14.3 Joints STANDARD_DEVIATION 9.66 |
| Body Mass Index (BMI) | 30.119 kg/m^2 STANDARD_DEVIATION 5.7386 | 30.873 kg/m^2 STANDARD_DEVIATION 7.6362 | 28.553 kg/m^2 STANDARD_DEVIATION 8.3143 | 27.012 kg/m^2 STANDARD_DEVIATION 4.9291 | 33.029 kg/m^2 STANDARD_DEVIATION 5.8922 | 36.426 kg/m^2 STANDARD_DEVIATION 9.9918 |
| Cutaneous Lupus Area and Severity Index Activity Score (CLASI) Activity Score | 17.6 units on a scale STANDARD_DEVIATION 12.89 | 9.8 units on a scale STANDARD_DEVIATION 11.76 | 12.4 units on a scale STANDARD_DEVIATION 16.48 | 8.4 units on a scale STANDARD_DEVIATION 8.63 | 4.3 units on a scale STANDARD_DEVIATION 5.9 | 6.3 units on a scale STANDARD_DEVIATION 9.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 7 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 35 Participants | 8 Participants | 8 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hybrid SELENA Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) | 8.4 Units on a Scale STANDARD_DEVIATION 4.07 | 6.6 Units on a Scale STANDARD_DEVIATION 2.79 | 5.7 Units on a Scale STANDARD_DEVIATION 1.87 | 6.7 Units on a Scale STANDARD_DEVIATION 3.16 | 6.8 Units on a Scale STANDARD_DEVIATION 1.83 | 5.5 Units on a Scale STANDARD_DEVIATION 2.07 |
| Physician's Global Assessment (PGA) | 1.50 Units on a Scale STANDARD_DEVIATION 0.648 | 1.31 Units on a Scale STANDARD_DEVIATION 0.565 | 1.40 Units on a Scale STANDARD_DEVIATION 0.598 | 1.22 Units on a Scale STANDARD_DEVIATION 0.353 | 0.95 Units on a Scale STANDARD_DEVIATION 0.518 | 1.50 Units on a Scale STANDARD_DEVIATION 0.614 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 13 Participants | 4 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 27 Participants | 5 Participants | 7 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Female | 8 Participants | 39 Participants | 9 Participants | 8 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 5 / 8 | 7 / 8 | 7 / 8 | 8 / 9 | 8 / 9 | 9 / 9 | 7 / 8 |
| serious Total, serious adverse events | 2 / 8 | 0 / 8 | 0 / 8 | 1 / 9 | 1 / 9 | 0 / 9 | 4 / 8 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time frame: From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts.
Population: The safety population included all participants who were randomized and received at least 1 dose of IP. For all participants, this was the treatment group to which they were randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE | 5 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any IP-related TEAE | 1 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Severe TEAE | 1 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious TEAE | 2 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious IP-related TEAE | 0 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Interruption | 0 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Withdrawal | 1 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to Death | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Severe TEAE | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Interruption | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE | 7 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious TEAE | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any IP-related TEAE | 2 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to Death | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious IP-related TEAE | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Withdrawal | 0 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Withdrawal | 0 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to Death | 0 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious TEAE | 0 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Interruption | 1 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Severe TEAE | 0 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any IP-related TEAE | 2 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE | 7 Participants |
| Part 1: Iberdomide 0.3 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious IP-related TEAE | 0 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any IP-related TEAE | 4 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Severe TEAE | 1 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious TEAE | 1 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious IP-related TEAE | 0 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Interruption | 1 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to Death | 0 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE | 8 Participants |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Withdrawal | 2 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious TEAE | 1 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to Death | 0 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Severe TEAE | 2 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Withdrawal | 3 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE | 8 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any TEAE Leading to IP Interruption | 5 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any IP-related TEAE | 6 Participants |
| Part 1: Iberdomide 0.6 mg QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase | Any Serious IP-related TEAE | 1 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase
A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.
Time frame: From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE Leading to IP Interruption | 2 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any IP-related TEAE | 2 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE Leading to Death | 0 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any Severe TEAE | 0 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE Leading to IP Withdrawal | 1 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any Serious TEAE | 0 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE | 9 Participants |
| Part 1: Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any Serious IP-related TEAE | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE | 7 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE Leading to IP Interruption | 5 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE Leading to IP Withdrawal | 4 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any TEAE Leading to Death | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any Serious IP-related TEAE | 0 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any IP-related TEAE | 5 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any Severe TEAE | 5 Participants |
| Part 1: Iberdomide 0.3 mg QOD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase | Any Serious TEAE | 4 Participants |
Secondary
Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide
The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time frame: Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Population: The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 1 | 10.82 ng*h/mL | Geometric Coefficient of Variation 17.9 |
| Part 1: Placebo | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 29 | 13.34 ng*h/mL | Geometric Coefficient of Variation 14.1 |
| Part 1: Iberdomide 0.3 mg QOD | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 29 | 15.55 ng*h/mL | Geometric Coefficient of Variation 1.8 |
| Part 1: Iberdomide 0.3 mg QOD | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 1 | 11.29 ng*h/mL | Geometric Coefficient of Variation 42.6 |
| Part 1: Iberdomide 0.3 mg QD | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 1 | 34.15 ng*h/mL | Geometric Coefficient of Variation 45.5 |
| Part 1: Iberdomide 0.3 mg QD | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 29 | 24.85 ng*h/mL | Geometric Coefficient of Variation 110.5 |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 1 | 38.73 ng*h/mL | Geometric Coefficient of Variation 76.5 |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide | Day 29 | 52.65 ng*h/mL | Geometric Coefficient of Variation 82.4 |
Secondary
Change From Baseline in Swollen Joint Count During the ATEP by Time Point
Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 24 | -2.1 Joints | Standard Deviation 5.84 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 60 | -2.6 Joints | Standard Deviation 5.74 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 12 | -2.6 Joints | Standard Deviation 4.81 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 72 | -4.0 Joints | Standard Deviation 5.1 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 36 | -3.9 Joints | Standard Deviation 4.67 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 84 | -4.2 Joints | Standard Deviation 5.49 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 4 | -1.8 Joints | Standard Deviation 2.99 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 96 | -3.7 Joints | Standard Deviation 5.75 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 48 | -3.6 Joints | Standard Deviation 5.35 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 100 Follow-Up | -3.6 Joints | Standard Deviation 5.26 |
| Part 1: Placebo | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 1 | -1.2 Joints | Standard Deviation 3.11 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 100 Follow-Up | -0.4 Joints | Standard Deviation 0.55 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 1 | -0.4 Joints | Standard Deviation 0.74 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 4 | -0.6 Joints | Standard Deviation 2.64 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 12 | -0.3 Joints | Standard Deviation 0.95 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 24 | 1.2 Joints | Standard Deviation 1.3 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 36 | -0.2 Joints | Standard Deviation 2.17 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 48 | 0.6 Joints | Standard Deviation 1.34 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 60 | 0.4 Joints | Standard Deviation 1.52 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 72 | 0.7 Joints | Standard Deviation 1.15 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 84 | 0.0 Joints | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Swollen Joint Count During the ATEP by Time Point | Week 96 | 0.0 Joints | — |
Secondary
Change From Baseline in Tender Joint Count During the ATEP by Time Point
Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 1 | -0.9 Joints | Standard Deviation 2.37 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 12 | 0.5 Joints | Standard Deviation 6.02 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 60 | -5.6 Joints | Standard Deviation 9.78 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 72 | -6.2 Joints | Standard Deviation 6.59 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 48 | -5.9 Joints | Standard Deviation 6.99 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 84 | -7.3 Joints | Standard Deviation 10.78 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 24 | -3.9 Joints | Standard Deviation 4.19 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 96 | -7.0 Joints | Standard Deviation 7.92 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 4 | -0.9 Joints | Standard Deviation 3.76 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 100 Follow-Up | -4.1 Joints | Standard Deviation 3.63 |
| Part 1: Placebo | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 36 | -5.1 Joints | Standard Deviation 5.3 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 100 Follow-Up | -1.4 Joints | Standard Deviation 3.44 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 1 | -2.5 Joints | Standard Deviation 4.63 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 4 | -2.0 Joints | Standard Deviation 3.27 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 12 | -3.7 Joints | Standard Deviation 7.67 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 24 | -3.6 Joints | Standard Deviation 10.97 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 36 | -3.8 Joints | Standard Deviation 9.65 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 48 | -3.0 Joints | Standard Deviation 8.97 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 72 | -6.7 Joints | Standard Deviation 12.42 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 84 | 0.0 Joints | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 96 | 0.0 Joints | — |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in Tender Joint Count During the ATEP by Time Point | Week 60 | -4.4 Joints | Standard Deviation 10.99 |
Secondary
Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point
The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 24 | -6.3 Units on a Scale | Standard Deviation 6.55 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 60 | -6.3 Units on a Scale | Standard Deviation 6.37 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 12 | -2.2 Units on a Scale | Standard Deviation 6.98 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 72 | -7.5 Units on a Scale | Standard Deviation 4.46 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Global Score Week 36 | -7.3 Units on a Scale | Standard Deviation 5.74 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 84 | -7.8 Units on a Scale | Standard Deviation 8.04 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 4 | 2.0 Units on a Scale | Standard Deviation 7.04 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 96 | -0.52 Units on a Scale | Standard Deviation 0.595 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 48 | -6.1 Units on a Scale | Standard Deviation 7.84 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Follow-Up Week 100 | -6.3 Units on a Scale | Standard Deviation 7.2 |
| Part 1: Placebo | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 1 | -0.5 Units on a Scale | Standard Deviation 5.76 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Follow-Up Week 100 | -3.9 Units on a Scale | Standard Deviation 4.62 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 1 | 3.3 Units on a Scale | Standard Deviation 5.38 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 4 | 0.7 Units on a Scale | Standard Deviation 9.03 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 12 | 2.0 Units on a Scale | Standard Deviation 6.03 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 24 | 3.0 Units on a Scale | Standard Deviation 5.6 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Global Score Week 36 | 1.6 Units on a Scale | Standard Deviation 9.13 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 48 | 1.4 Units on a Scale | Standard Deviation 5.68 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 60 | 0.4 Units on a Scale | Standard Deviation 4.83 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 72 | 4.3 Units on a Scale | Standard Deviation 8.5 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 84 | -1.0 Units on a Scale | Standard Deviation 1.41 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point | Week 96 | -0.20 Units on a Scale | — |
Secondary
Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 24 | 0.1 Units on a Scale | Standard Deviation 0.83 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 60 | 0.4 Units on a Scale | Standard Deviation 0.79 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 12 | -0.6 Units on a Scale | Standard Deviation 1.77 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 72 | 0.3 Units on a Scale | Standard Deviation 0.82 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 36 | 0.1 Units on a Scale | Standard Deviation 0.38 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 84 | 0.7 Units on a Scale | Standard Deviation 1.63 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 4 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 96 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 48 | 0.3 Units on a Scale | Standard Deviation 0.76 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Follow-Up Week 100 | -0.3 Units on a Scale | Standard Deviation 1.25 |
| Part 1: Placebo | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 1 | -0.1 Units on a Scale | Standard Deviation 0.33 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Follow-Up Week 100 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 1 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 4 | -1.0 Units on a Scale | Standard Deviation 2.24 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 12 | -0.9 Units on a Scale | Standard Deviation 2.73 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 24 | -2.2 Units on a Scale | Standard Deviation 4.38 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 36 | -2.2 Units on a Scale | Standard Deviation 4.38 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 48 | -2.4 Units on a Scale | Standard Deviation 4.83 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 60 | -2.6 Units on a Scale | Standard Deviation 5.81 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 72 | -0.7 Units on a Scale | Standard Deviation 1.15 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 84 | -1.0 Units on a Scale | Standard Deviation 1.41 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point | Week 96 | 0.0 Units on a Scale | — |
Secondary
Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point
The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an X representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 12 | -15.9 Units on a Scale | Standard Deviation 30.77 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 48 | -29.9 Units on a Scale | Standard Deviation 20.58 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 4 | -4.1 Units on a Scale | Standard Deviation 16.96 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 60 | -23.0 Units on a Scale | Standard Deviation 20.65 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 24 | -13.6 Units on a Scale | Standard Deviation 17.27 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 72 | -22.8 Units on a Scale | Standard Deviation 26.96 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 1 | -10.0 Units on a Scale | Standard Deviation 20.3 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 84 | -10.3 Units on a Scale | Standard Deviation 24.61 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 36 | -21.1 Units on a Scale | Standard Deviation 20.96 |
| Part 1: Placebo | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 96 | -9.8 Units on a Scale | Standard Deviation 34.52 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 96 | -20.0 Units on a Scale | — |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 1 | -4.0 Units on a Scale | Standard Deviation 13.48 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 4 | -3.7 Units on a Scale | Standard Deviation 12.23 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 12 | -8.0 Units on a Scale | Standard Deviation 20.6 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 24 | -4.0 Units on a Scale | Standard Deviation 8.8 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 36 | -17.2 Units on a Scale | Standard Deviation 17.48 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 48 | -12.8 Units on a Scale | Standard Deviation 14.48 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 60 | -12.6 Units on a Scale | Standard Deviation 10.74 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 72 | -25.7 Units on a Scale | Standard Deviation 19.55 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point | Week 84 | -14.0 Units on a Scale | Standard Deviation 19.8 |
Secondary
Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point
The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 84 | -3.0 Units on a Scale | Standard Deviation 1.67 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 12 | -1.8 Units on a Scale | Standard Deviation 2.92 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 72 | -3.0 Units on a Scale | Standard Deviation 1.67 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 24 | -2.8 Units on a Scale | Standard Deviation 2.6 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 96 | -2.0 Units on a Scale | Standard Deviation 1.79 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 36 | -3.1 Units on a Scale | Standard Deviation 1.95 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 1 | 0.2 Units on a Scale | Standard Deviation 1.56 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 48 | -2.9 Units on a Scale | Standard Deviation 1.95 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 60 | -2.6 Units on a Scale | Standard Deviation 1.9 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 100 Follow-Up | -1.7 Units on a Scale | Standard Deviation 2.43 |
| Part 1: Placebo | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 4 | 0.2 Units on a Scale | Standard Deviation 1.56 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 100 Follow-Up | 0.3 Units on a Scale | Standard Deviation 1.71 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 60 | -1.8 Units on a Scale | Standard Deviation 4.02 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 72 | -1.3 Units on a Scale | Standard Deviation 1.15 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 84 | -1.0 Units on a Scale | Standard Deviation 1.41 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 1 | -1.0 Units on a Scale | Standard Deviation 2.39 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 4 | -1.7 Units on a Scale | Standard Deviation 2.93 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 12 | -0.9 Units on a Scale | Standard Deviation 1.07 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 24 | -1.2 Units on a Scale | Standard Deviation 2.59 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 36 | 0.3 Units on a Scale | Standard Deviation 2.06 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 96 | 0.0 Units on a Scale | — |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point | Week 48 | -1.0 Units on a Scale | Standard Deviation 2.65 |
Secondary
Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt
The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 24 | -1.0 Units on a Scale | Standard Deviation 2.88 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 60 | -1.1 Units on a Scale | Standard Deviation 3.18 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 12 | -1.1 Units on a Scale | Standard Deviation 2.67 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 72 | 0.2 Units on a Scale | Standard Deviation 1.57 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 36 | -0.7 Units on a Scale | Standard Deviation 3.3 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 84 | 0.2 Units on a Scale | Standard Deviation 0.98 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 4 | -0.8 Units on a Scale | Standard Deviation 2.74 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 96 | -0.2 Units on a Scale | Standard Deviation 0.98 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 48 | -1.4 Units on a Scale | Standard Deviation 2.99 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Follow-Up Week 100 | -0.6 Units on a Scale | Standard Deviation 0.98 |
| Part 1: Placebo | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 1 | -1.0 Units on a Scale | Standard Deviation 2.65 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Follow-Up Week 100 | 0.2 Units on a Scale | Standard Deviation 1.1 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 1 | 0.8 Units on a Scale | Standard Deviation 1.49 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 4 | 0.9 Units on a Scale | Standard Deviation 2.01 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 12 | 1.3 Units on a Scale | Standard Deviation 2.21 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 24 | 0.6 Units on a Scale | Standard Deviation 1.34 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 36 | 0.7 Units on a Scale | Standard Deviation 1.57 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 48 | 0.9 Units on a Scale | Standard Deviation 2.01 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 60 | 1.1 Units on a Scale | Standard Deviation 2.41 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 72 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 84 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt | Week 96 | 0.0 Units on a Scale | — |
Secondary
Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point
The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: * 0 = none * 1 = mild disease * 2 = moderate disease * 3 = severe disease
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Follow-Up Week 100 | -0.21 Units on a Scale | Standard Deviation 0.769 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 1 | -0.08 Units on a Scale | Standard Deviation 0.139 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 4 | -0.26 Units on a Scale | Standard Deviation 0.51 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 12 | -0.15 Units on a Scale | Standard Deviation 0.407 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 24 | -0.28 Units on a Scale | Standard Deviation 0.686 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 36 | -0.30 Units on a Scale | Standard Deviation 0.141 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 48 | -0.53 Units on a Scale | Standard Deviation 0.556 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 60 | -0.37 Units on a Scale | Standard Deviation 0.55 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 72 | -0.48 Units on a Scale | Standard Deviation 0.471 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 84 | -0.57 Units on a Scale | Standard Deviation 0.468 |
| Part 1: Placebo | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 96 | -0.52 Units on a Scale | Standard Deviation 0.595 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 96 | -0.20 Units on a Scale | — |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 48 | -0.26 Units on a Scale | Standard Deviation 0.594 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 1 | -0.10 Units on a Scale | Standard Deviation 0.245 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 84 | -0.30 Units on a Scale | Standard Deviation 0.707 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 4 | -0.17 Units on a Scale | Standard Deviation 0.407 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 60 | -0.24 Units on a Scale | Standard Deviation 0.498 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 12 | -0.31 Units on a Scale | Standard Deviation 0.389 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Follow-Up Week 100 | 0.10 Units on a Scale | Standard Deviation 0.354 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 24 | -0.20 Units on a Scale | Standard Deviation 0.394 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 72 | -0.23 Units on a Scale | Standard Deviation 0.666 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point | Week 36 | -0.36 Units on a Scale | Standard Deviation 0.59 |
Secondary
Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point
SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 24 | -0.1 Units on a Scale | Standard Deviation 0.35 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 60 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 12 | -0.1 Units on a Scale | Standard Deviation 0.35 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 72 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 36 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 84 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 4 | -0.1 Units on a Scale | Standard Deviation 0.33 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 96 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 48 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Follow-Up Week 100 | 0.6 Units on a Scale | Standard Deviation 1.13 |
| Part 1: Placebo | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 1 | -0.1 Units on a Scale | Standard Deviation 0.33 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Follow-Up Week 100 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 1 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 4 | -0.1 Units on a Scale | Standard Deviation 0.38 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 12 | -0.1 Units on a Scale | Standard Deviation 0.38 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 24 | -0.2 Units on a Scale | Standard Deviation 0.45 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 36 | -0.2 Units on a Scale | Standard Deviation 0.45 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 48 | -0.2 Units on a Scale | Standard Deviation 0.45 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 60 | -0.2 Units on a Scale | Standard Deviation 0.45 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 72 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 84 | 0.0 Units on a Scale | Standard Deviation 0 |
| Part 1: Iberdomide 0.3 mg QOD | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point | Week 96 | 0.0 Units on a Scale | — |
Secondary
Maximum Observed Concentration (Cmax) Of Iberdomide
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time frame: Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Population: The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 1 | 0.90 ng/mL | Geometric Coefficient of Variation 41.3 |
| Part 1: Placebo | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 29 | 1.02 ng/mL | Geometric Coefficient of Variation 4.3 |
| Part 1: Iberdomide 0.3 mg QOD | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 29 | 1.09 ng/mL | Geometric Coefficient of Variation 1.8 |
| Part 1: Iberdomide 0.3 mg QOD | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 1 | 0.64 ng/mL | Geometric Coefficient of Variation 42.4 |
| Part 1: Iberdomide 0.3 mg QD | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 1 | 2.92 ng/mL | Geometric Coefficient of Variation 50.6 |
| Part 1: Iberdomide 0.3 mg QD | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 29 | 2.37 ng/mL | Geometric Coefficient of Variation 42.7 |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 1 | 2.35 ng/mL | Geometric Coefficient of Variation 63.1 |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Maximum Observed Concentration (Cmax) Of Iberdomide | Day 29 | 3.51 ng/mL | Geometric Coefficient of Variation 51.7 |
Secondary
Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point
The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP. The number analyzed at each time point includes participants with a baseline value \>= 4 and non-missing post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 24 | 83.3 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 60 | 33.3 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 12 | 66.7 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 72 | 80.0 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 36 | 66.7 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 84 | 80.0 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 4 | 0.0 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 96 | 40.0 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 48 | 50.0 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 100 Follow-Up | 40.0 Percentage of Participants |
| Part 1: Placebo | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 1 | 0.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 100 Follow-Up | 0.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 1 | 12.5 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 4 | 14.3 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 12 | 0.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 24 | 20.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 36 | 0.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 48 | 20.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 60 | 20.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 72 | 0.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 84 | 0.0 Percentage of Participants |
| Part 1: Iberdomide 0.3 mg QOD | Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point | Week 96 | 0.0 Percentage of Participants |
Secondary
Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point
The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.
Time frame: Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.
Population: The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 24 | 13.54 Percent Change | Standard Deviation 147.03 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 60 | -65.64 Percent Change | Standard Deviation 40.889 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 12 | -18.42 Percent Change | Standard Deviation 68.423 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 72 | -55.13 Percent Change | Standard Deviation 41.583 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 36 | -0.56 Percent Change | Standard Deviation 116.911 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 84 | -65.71 Percent Change | Standard Deviation 24.535 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 4 | -32.13 Percent Change | Standard Deviation 45.4 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 96 | -75.38 Percent Change | Standard Deviation 23.492 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 48 | -46.97 Percent Change | Standard Deviation 44.154 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Follow-Up Week 100 | -53.04 Percent Change | Standard Deviation 39.635 |
| Part 1: Placebo | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 1 | -21.40 Percent Change | Standard Deviation 40.529 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Follow-Up Week 100 | -18.82 Percent Change | Standard Deviation 37.296 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 1 | -13.35 Percent Change | Standard Deviation 28.556 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 4 | -18.32 Percent Change | Standard Deviation 58.924 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 12 | -36.46 Percent Change | Standard Deviation 33.648 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 24 | -44.69 Percent Change | Standard Deviation 24.366 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 36 | -43.98 Percent Change | Standard Deviation 31.724 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 48 | -46.00 Percent Change | Standard Deviation 22.343 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 60 | -47.51 Percent Change | Standard Deviation 28.871 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 72 | -40.35 Percent Change | Standard Deviation 9.924 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 84 | -32.46 Percent Change | Standard Deviation 1.241 |
| Part 1: Iberdomide 0.3 mg QOD | Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point | Week 96 | -26.32 Percent Change | — |
Secondary
Terminal Phase Half-Life (T1/2) Of Iberdomide
Terminal phase half-life in plasma, calculated as \[(In 2)/λz\]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time frame: Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Population: The Pharmacokinetic population included all participants in the safety population with at least one non-missing plasma concentration datum available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 1 | 7.50 days | — |
| Part 1: Placebo | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 29 | 8.46 days | — |
| Part 1: Iberdomide 0.3 mg QOD | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 29 | 11.85 days | Geometric Coefficient of Variation 4.1 |
| Part 1: Iberdomide 0.3 mg QOD | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 1 | 10.25 days | — |
| Part 1: Iberdomide 0.3 mg QD | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 1 | 7.96 days | Geometric Coefficient of Variation 22.8 |
| Part 1: Iberdomide 0.3 mg QD | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 29 | 9.39 days | Geometric Coefficient of Variation 11.1 |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 1 | 9.55 days | Geometric Coefficient of Variation 0.2 |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Terminal Phase Half-Life (T1/2) Of Iberdomide | Day 29 | 11.32 days | Geometric Coefficient of Variation 4.8 |
Secondary
Time to Reach Maximum Concentration (Tmax) of Iberdomide
Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.
Time frame: Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.
Population: The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Placebo | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 1 | 4.00 days |
| Part 1: Placebo | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 29 | 4.00 days |
| Part 1: Iberdomide 0.3 mg QOD | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 29 | 2.00 days |
| Part 1: Iberdomide 0.3 mg QOD | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 1 | 6.00 days |
| Part 1: Iberdomide 0.3 mg QD | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 1 | 1.92 days |
| Part 1: Iberdomide 0.3 mg QD | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 29 | 3.00 days |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 1 | 4.01 days |
| Part 1: Iberdomide 0.6 mg/0.3 mg ALT Days | Time to Reach Maximum Concentration (Tmax) of Iberdomide | Day 29 | 2.02 days |