Trial · NCT01972568
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
NCT01972568, Phase 2, Completed, EMD Serono; results first posted 2017-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus. Trials, record NCT01972568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01972568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
- NCT number
- NCT01972568
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 306 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Atacicept 75 milligram (mg), Atacicept 150 mg, Placebo
- First posted
- 2013-10-30
- Last updated
- 2018-01-02
- Other registries' IDs
- eudract:2013-002773-21
- Results first posted
- 2017-10-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline | Week 24 | 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. |
| Primary | Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline | Week 24 | 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. |
| Secondary | 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 | Week 24 | 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. |
| Secondary | Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 | 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. |
| Secondary | Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24 | Screening and Week 24 | Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented. |
| Secondary | Time From Randomization to First SRI Response During Treatment Period | Baseline up to 24 Weeks | 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. |
| Secondary | Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24 | 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. |
| Secondary | Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks) | 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. |
| Secondary | Change From Week 0 (Day 1) in SF-36 Components at Week 24 | Week 0 (Day 1) and 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline | Week 24 | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. | percentage of subjects | NUMBER |
| SECONDARY | 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 | Week 24 | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here Number of Participants Analyzed signifies those subjects whose CS dose \>=10 mg at Screening. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 | Week 24 | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. | percentage of subjects | NUMBER |
| SECONDARY | Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24 | Screening and Week 24 | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. | mg per day | MEAN |
| SECONDARY | Time From Randomization to First SRI Response During Treatment Period | Baseline up to 24 Weeks | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. | weeks | MEDIAN |
| SECONDARY | Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24 | Week 24 | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks) | Safety analysis set included all randomized subjects who received at least 1 dose of IMP. | percentage of subjects | NUMBER |
| SECONDARY | Change From Week 0 (Day 1) in SF-36 Components at Week 24 | Week 0 (Day 1) and Week 24 | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure at specified categories. | units on a scale | MEAN |
| POST_HOC | High Disease Activity Subpopulation (SLEDAI-2K >=10 at Screening): Logistic Regression of Percentage of Subjects With SRI-6 Response at Week 24 | Week 24 | mITT\_HDA analysis set included mITT population with high disease activity (HDA) defined as screening SLE Disease Activity Index (SLEDAI) \>=10. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline | Week 24 | mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline | Atacicept 75 mg | 57.8 | percentage of subjects | ||
| Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline | Atacicept 150 mg | 53.8 | percentage of subjects | ||
| Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline | Placebo | 44.0 | percentage of subjects | ||
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 | Atacicept 75 mg | 17.9 | percentage of subjects | ||
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 | Atacicept 150 mg | 11.3 | percentage of subjects | ||
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 | Placebo | 18.9 | percentage of subjects | ||
| Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 | Atacicept 75 mg | Very much or much improved | 57.8 | percentage of subjects | |
| Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 | Atacicept 150 mg | Very much or much improved | 53.8 | percentage of subjects | |
| Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 | Placebo | Very much or much improved | 46.0 | percentage of subjects | |
| Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24 | Atacicept 75 mg | Minimally improved or no change or minimally worse | 39.2 | percentage of subjects |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atacicept 75 mg | 102 | |
| Overall Study | STARTED | Atacicept 150 mg | 104 | |
| Overall Study | STARTED | Placebo | 100 | |
| Overall Study | COMPLETED | Atacicept 75 mg | 86 | |
| Overall Study | COMPLETED | Atacicept 150 mg | 92 | |
| Overall Study | COMPLETED | Placebo | 84 | |
| Overall Study | NOT COMPLETED | Atacicept 75 mg | 16 | |
| Overall Study | NOT COMPLETED | Atacicept 150 mg | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events189
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Atacicept 75 mg | 8 | 102 | |
| other | Diarrhoea | Gastrointestinal disorders | Atacicept 150 mg | 12 | 104 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 100 | |
| other | Nausea | Gastrointestinal disorders | Atacicept 75 mg | 9 | 102 | |
| other | Nausea | Gastrointestinal disorders | Atacicept 150 mg | 5 | 104 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 100 | |
| other | Fatigue | General disorders | Atacicept 75 mg | 6 | 102 | |
| other | Fatigue | General disorders | Atacicept 150 mg | 3 | 104 | |
| other | Fatigue | General disorders | Placebo | 2 | 100 | |
| other | Injection site pain | General disorders | Atacicept 75 mg | 12 | 102 |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atacicept 75 mg | ||
| Total, all-cause mortality | Atacicept 150 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Atacicept 75 mg | 83 | 102 |
| Total, other adverse events | Atacicept 150 mg | 84 | 104 |
| Total, other adverse events | Placebo | 72 | 100 |
| Total, serious adverse events | Atacicept 75 mg | 9 | 102 |
| Total, serious adverse events | Atacicept 150 mg | 6 | 104 |
| Total, serious adverse events | Placebo | 12 | 100 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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