A Phase 2 interventional study of Atacicept 75 milligram (mg) and Atacicept 150 mg in Lupus Erythematosus, Systemic, sponsored by EMD Serono. Completed at 138 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by EMD Serono · Phase 2, Interventional, and Treatment
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 306 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Atacicept 75 milligram (mg)
Drug: Atacicept 150 mg
Drug: Placebo
Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
Time frame: Week 24
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
Time frame: Week 24
Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity
BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone \>20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.
Time frame: Week 24
Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24
The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.
Time frame: Week 24
Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24
Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.
Time frame: Screening and Week 24
Time From Randomization to First SRI Response During Treatment Period
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.
Time frame: Baseline up to 24 Weeks
Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24
The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and \<=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by \<10% (defined as \<0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.
Time frame: Week 24
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Time frame: Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)
Change From Week 0 (Day 1) in SF-36 Components at Week 24
The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.
Time frame: Week 0 (Day 1) and Week 24
The study was conducted at 136 sites in 18 countries in Asia, Europe, North America, Central America, and South America.
| Milestone | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Started | 102 | 104 | 100 |
| Completed | 86 | 92 | 84 |
| Not completed | 16 | 12 | 16 |
| Withdrew: Other events | 3 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 2 |
| Withdrew: Protocol violation | 1 | 2 | 2 |
| Withdrew: Withdrawal by subject | 6 | 3 | 7 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Adverse event | 5 | 6 | 5 |
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
| percentage of subjects | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline | 57.8 | 53.8 | 44.0 |
BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone \>20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.
| percentage of subjects | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity | 17.9 | 11.3 | 18.9 |
The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.
| percentage of subjects | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Very much or much improved | 57.8 | 53.8 | 46.0 |
| Minimally improved or no change or minimally worse | 39.2 | 44.2 | 46.0 |
| Much or very much worse | 2.0 | 1.0 | 6.0 |
| Missing | 1.0 | 1.0 | 2.0 |
Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.
| mg per day | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24 | -2.64 ± 6.106 | -1.87 ± 4.653 | -1.89 ± 5.588 |
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.
| weeks | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Time From Randomization to First SRI Response During Treatment Period | 12.4 (12.1 to 16.7) | 16.1 (12.0 to 16.4) | 16.1 (12.1 to 20.1) |
The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and \<=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by \<10% (defined as \<0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.
| percentage of subjects | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24 | 53.4 | 49.0 | 45.2 |
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
| percentage of subjects | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| TEAEs | 81.4 | 80.8 | 72.0 |
| Serious TEAEs | 8.8 | 5.8 | 12.0 |
The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.
| units on a scale | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Physical Component Summary | 4.7 ± 7.95 | 3.4 ± 7.57 | 3.5 ± 10.33 |
| Mental Component Summary | 1.9 ± 12.01 | 1.8 ± 9.08 | 0.7 ± 11.44 |
| Physical Functioning | 3.5 ± 9.30 | 3.8 ± 8.42 | 3.3 ± 8.62 |
| Role-Physical | 4.3 ± 10.26 | 2.3 ± 8.64 | 3.9 ± 9.51 |
| Bodily Pain | 6.0 ± 10.22 | 4.4 ± 9.30 | 5.6 ± 10.72 |
| General Health | 2.9 ± 8.43 | 3.0 ± 7.72 | 4.4 ± 8.00 |
| Vitality | 3.9 ± 9.86 | 3.7 ± 9.76 | 3.5 ± 9.57 |
| Social Functioning | 3.8 ± 11.45 | 2.2 ± 10.06 | 4.3 ± 11.08 |
| Role-Emotional | 2.5 ± 12.71 | 1.0 ± 10.43 | 2.3 ± 10.99 |
| Mental Health | 2.3 ± 12.30 | 2.8 ± 8.87 | 2.1 ± 10.60 |
SRI-6 response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 6 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score. Logistic regression of number of subjects with SRI-6 response was analyzed by using Logistic regression model.
| percentage of subjects | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| High Disease Activity Subpopulation (SLEDAI-2K >=10 at Screening): Logistic Regression of Percentage of Subjects With SRI-6 Response at Week 24 | 43.6 | 54.9 | 28.8 |
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (\<10 % increase, defined as \<0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and \<=1 (defined as no more than one) new BILAG B organ domain score.
| percentage of subjects | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline | 55.9 | 55.8 | 41.0 |
Collected over Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atacicept 75 mg | — | 9/102 (8.8%) | 83/102 (81.4%) |
| Atacicept 150 mg | — | 6/104 (5.8%) | 84/104 (80.8%) |
| Placebo | — | 12/100 (12%) | 72/100 (72%) |
| Event | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 1/102 | 0/104 | 2/100 |
| Acute kidney injuryRenal and urinary disorders | 0/102 | 0/104 | 2/100 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/102 | 0/104 | 1/100 |
| Angina pectorisCardiac disorders | 0/102 | 0/104 | 1/100 |
| Cardiac failure congestiveCardiac disorders | 0/102 | 0/104 | 1/100 |
| Mitral valve prolapseCardiac disorders | 0/102 | 0/104 | 1/100 |
| Right ventricular dilatationCardiac disorders | 0/102 | 0/104 | 1/100 |
| DyspepsiaGastrointestinal disorders | 0/102 | 0/104 | 1/100 |
| AppendicitisInfections and infestations | 0/102 | 0/104 | 1/100 |
| BronchitisInfections and infestations | 1/102 | 0/104 | 1/100 |
| Event | Atacicept 75 mg | Atacicept 150 mg | Placebo |
|---|---|---|---|
| Injection site reactionGeneral disorders | 42/102 | 43/104 | 19/100 |
| Urinary tract infectionInfections and infestations | 12/102 | 12/104 | 17/100 |
| HeadacheNervous system disorders | 11/102 | 15/104 | 8/100 |
| Injection site painGeneral disorders | 12/102 | 14/104 | 7/100 |
| Upper respiratory tract infectionInfections and infestations | 10/102 | 13/104 | 3/100 |
| DiarrhoeaGastrointestinal disorders | 8/102 | 12/104 | 5/100 |
| NauseaGastrointestinal disorders | 9/102 | 5/104 | 1/100 |
| Back painMusculoskeletal and connective tissue disorders | 4/102 | 3/104 | 7/100 |
| NasopharyngitisInfections and infestations | 6/102 | 7/104 | 5/100 |
| FatigueGeneral disorders | 6/102 | 3/104 | 2/100 |
Modified intent-to-treat (mITT) analysis set included all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
| Age, Continuous(years) | Atacicept 75 mg | Atacicept 150 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 37 ± 11.2 | 39 ± 11.6 | 40 ± 13.0 | 39 ± 11.9 |
| Sex: Female, Male(Participants) | Atacicept 75 mg | Atacicept 150 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 93 | 97 | 90 | 280 |
| Male | 9 | 7 | 10 | 26 |
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Lupus Erythematosus, Systemic→
EMD Serono