Trial · NCT00624338

Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

NCT00624338, Phase 2, Phase 3, Completed, EMD Serono; results first posted 2016-03-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE). Trials, record NCT00624338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00624338

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
NCT number: NCT00624338
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 461 participants, actual
Lead sponsor: EMD Serono
Conditions: Lupus Erythematosus, Systemic
Interventions: Atacicept 75 mg, Atacicept 150 mg, Placebo Comparator
First posted: 2008-02-27
Last updated: 2016-03-14
Results first posted: 2016-03-14
Limitations and caveats: Atacicept 150 mg group was discontinued on 2 February 2011 based on the recommendation from the Independent Data Monitoring Committee.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B	From screening up to Week 52	A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. 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 greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Secondary	Time to First New Flare as Defined by BILAG Score A or B	From screening up to Week 52	A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment. Analysis was right-censored at Week 52. The hazard ratios and 95% confidence intervals were obtained from the Cox proportional hazards model. The 25th Percentile of time to new flare was reported using Kaplan-Meier estimates (Median was not reached). The BILAG disease activity index evaluates 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 greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Secondary	Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks	From screening up to Week 24	A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. The BILAG disease activity index evaluates 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 greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Secondary	Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares	Week 52	Ordinal response categories have been defined as: 1) No BILAG A, no BILAG B, and completed treatment, 2) No BILAG A, at least 1 BILAG B during treatment period, and 3) At least 1 BILAG A during treatment period. The BILAG disease activity index evaluates 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 greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, NSAIDs, or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
Secondary	Mean Cumulative Corticosteroid Dose	Randomization up to Week 52

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B	From screening up to Week 52	Modified intent-to-treat (MITT) population included all the randomized participants who received study treatment.	percentage of participants	NUMBER
SECONDARY	Time to First New Flare as Defined by BILAG Score A or B	From screening up to Week 52	MITT population included all the randomized participants who received study treatment	days	NUMBER
SECONDARY	Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks	From screening up to Week 24	MITT population included all the randomized participants who received study treatment.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares	Week 52	MITT population included all the randomized participants who received study treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.	percentage of participants	NUMBER
SECONDARY	Mean Cumulative Corticosteroid Dose	Randomization up to Week 52	MITT population included all the randomized participants who received study treatment.	mg	MEAN

Source ClinicalTrials.gov

Results by group21

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B	Atacicept 75 mg		57.32		percentage of participants
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B	Atacicept 150 mg		36.11		percentage of participants
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B	Placebo		53.25		percentage of participants
Time to First New Flare as Defined by BILAG Score A or B	Atacicept 75 mg		143	95% Confidence Interval 112 to 226	days
Time to First New Flare as Defined by BILAG Score A or B	Atacicept 150 mg		310	95% Confidence Interval 169 to NA	days
Time to First New Flare as Defined by BILAG Score A or B	Placebo		142	95% Confidence Interval 87 to 197	days
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks	Atacicept 75 mg		40.13		percentage of participants
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks	Atacicept 150 mg		28.47		percentage of participants
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks	Placebo		35.06		percentage of participants
Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares	Atacicept 75 mg	No BILAG A, no BILAG B, and completed treatment	52.3		percentage of participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Atacicept 75 mg	159
Overall Study	STARTED	Atacicept 150 mg	145
Overall Study	STARTED	Placebo	157
Overall Study	Treated	Atacicept 75 mg	157
Overall Study	Treated	Atacicept 150 mg	144
Overall Study	Treated	Placebo	154
Overall Study	COMPLETED	Atacicept 75 mg	112
Overall Study	COMPLETED	Atacicept 150 mg	62
Overall Study	COMPLETED	Placebo	111
Overall Study	NOT COMPLETED	Atacicept 75 mg	47

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events402

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
other	Upper respiratory tract infection	Infections and infestations	Atacicept 75 mg	24	157
other	Upper respiratory tract infection	Infections and infestations	Atacicept 150 mg	27	144
other	Upper respiratory tract infection	Infections and infestations	Placebo	24	154
other	Urinary tract infection	Infections and infestations	Atacicept 75 mg	22	157
other	Urinary tract infection	Infections and infestations	Atacicept 150 mg	23	144
other	Urinary tract infection	Infections and infestations	Placebo	17	154
other	Nasopharyngitis	Infections and infestations	Atacicept 75 mg	21	157
other	Nasopharyngitis	Infections and infestations	Atacicept 150 mg	16	144
other	Nasopharyngitis	Infections and infestations	Placebo	11	154
other	Bronchitis	Infections and infestations	Atacicept 75 mg	12	157

1 to 10 of 402Source ClinicalTrials.gov

See all 402 adverse events

Adverse 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	129	157
Total, other adverse events	Atacicept 150 mg	120	144
Total, other adverse events	Placebo	118	154
Total, serious adverse events	Atacicept 75 mg	30	157
Total, serious adverse events	Atacicept 150 mg	23	144
Total, serious adverse events	Placebo	27	154

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24951103	DERIVED	PubMed
36532058	DERIVED	PubMed
37332136	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00624338

GET https://conductscience.org/api/trials/v1/NCT00624338/results?page=2

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