Trial · NCT02847598

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

NCT02847598, Phase 2, Completed, Biogen; results first posted 2023-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE). Trials, record NCT02847598. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02847598

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Trial

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

Title: Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
NCT number: NCT02847598
Status: Completed
Phases: Phase 2
Enrollment: 264 participants, actual
Lead sponsor: Biogen
Conditions: Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus
Interventions: BIIB059 (litifilimab), Placebo
First posted: 2016-07-28
Last updated: 2023-11-07
Other registries' IDs: eudract:2015-004359-32
Results first posted: 2023-05-15

Source ClinicalTrials.gov

Registered outcomes36

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

List	Outcome	Time frame	Description
Primary	Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	Baseline to Week 24	An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
Primary	Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16	Baseline to Week 16	The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Secondary	Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24	Week 24	CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Secondary	Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16	Week 12, Week 16	CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Secondary	Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24	Baseline, Week 12, 16 and 24	The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Secondary	Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12	Baseline, Week 12	The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Secondary	Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	Week 24	The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=4-point reduction from baseline in CLASI-A score are reported here.
Secondary	Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16	Week 12, Week 16	The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=4-point reduction from baseline in CLASI-A score are reported here.
Secondary	Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	Week 24	The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=7-point reduction from baseline in CLASI-A score are reported here.
Secondary	Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16	Week 12, Week 16	The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a \>=7-point reduction from baseline in CLASI-A score are reported here.

1 to 10 of 36Source ClinicalTrials.gov

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Outcomes36

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	Baseline to Week 24	MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.	joints	MEAN
PRIMARY	Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16	Baseline to Week 16	MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.	percent change	MEAN
SECONDARY	Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24	Week 24	MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies those with baseline CLASI-A \>=8 following protocol amendment.	percentage of participants	NUMBER
SECONDARY	Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16	Week 12, Week 16	MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number analyzed signifies number of participants analyzed at specific timepoint.	percentage of participants	NUMBER
SECONDARY	Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24	Baseline, Week 12, 16 and 24	MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint.	percent change	MEAN
SECONDARY	Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12	Baseline, Week 12	MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participant analyzed in this outcome measure.	percent change	MEAN
SECONDARY	Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	Week 24	MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.	percentage of participants	NUMBER
SECONDARY	Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16	Week 12, Week 16	MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of analyzed signifies number of participants analyzed at specific timepoint.	percentage of participants	NUMBER
SECONDARY	Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24	Week 24	MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure.	percentage of participants	NUMBER
SECONDARY	Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16	Week 12, Week 16	MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number analyzed signifies number of participants analyzed at specific timepoint.	percentage of participants	NUMBER

1 to 10 of 36Source ClinicalTrials.gov

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Results by group758

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

Outcome	Group	Value	Spread	Units
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	Part A: Placebo	-12.7	Standard Deviation 10.3	joints
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	Part A: BIIB059 50 mg	-9.0	Standard Deviation 5.7	joints
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	Part A: BIIB059 150 mg	-13.0	Standard Deviation NA	joints
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24	Part A: BIIB059 450 mg	-14.5	Standard Deviation 8.7	joints
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16	Part B: Placebo	-15.03	Standard Deviation 37.23	percent change
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16	Part B: BIIB059 50 mg	-35.52	Standard Deviation 33.35	percent change
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16	Part B: BIIB059 150 mg	-47.11	Standard Deviation 34.10	percent change
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16	Part B: BIIB059 450 mg	-41.66	Standard Deviation 37.33	percent change
Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24	Part A: Placebo	42.11		percentage of participants
Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24	Part A: BIIB059 50 mg	50		percentage of participants

1 to 10 of 758Source ClinicalTrials.gov

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Participant flow24

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Part A: Placebo	56
Overall Study	STARTED	Part A: BIIB059 50 mg	6
Overall Study	STARTED	Part A: BIIB059 150 mg	6
Overall Study	STARTED	Part A: BIIB059 450 mg	64
Overall Study	STARTED	Part B: Placebo	33
Overall Study	STARTED	Part B: BIIB059 50 mg	26
Overall Study	STARTED	Part B: BIIB059 150 mg	25
Overall Study	STARTED	Part B: BIIB059 450 mg	48
Overall Study	COMPLETED	Part A: Placebo	51
Overall Study	COMPLETED	Part A: BIIB059 50 mg	6

1 to 10 of 24Source ClinicalTrials.gov

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Adverse events560

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	Diarrhoea	Gastrointestinal disorders	Part A: Placebo	3	56
other	Diarrhoea	Gastrointestinal disorders	Part A: BIIB059 50 mg	1	6
other	Diarrhoea	Gastrointestinal disorders	Part A: BIIB059 150 mg	1	6
other	Diarrhoea	Gastrointestinal disorders	Part A: BIIB059 450 mg	3	64
other	Diarrhoea	Gastrointestinal disorders	Part B: Placebo	0	33
other	Diarrhoea	Gastrointestinal disorders	Part B: BIIB059 50 mg	0	26
other	Diarrhoea	Gastrointestinal disorders	Part B: BIIB059 150 mg	0	25
other	Diarrhoea	Gastrointestinal disorders	Part B: BIIB059 450 mg	0	48
other	Nausea	Gastrointestinal disorders	Part A: Placebo	0	56
other	Nausea	Gastrointestinal disorders	Part A: BIIB059 50 mg	1	6

1 to 10 of 560Source ClinicalTrials.gov

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Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part A: Placebo	3	56
Total, all-cause mortality	Part A: BIIB059 50 mg	0	6
Total, all-cause mortality	Part A: BIIB059 150 mg	0	6
Total, all-cause mortality	Part A: BIIB059 450 mg	0	64
Total, all-cause mortality	Part B: Placebo	0	33
Total, all-cause mortality	Part B: BIIB059 50 mg	0	26
Total, all-cause mortality	Part B: BIIB059 150 mg	0	25
Total, all-cause mortality	Part B: BIIB059 450 mg	0	48
Total, other adverse events	Part A: Placebo	22	56
Total, other adverse events	Part A: BIIB059 50 mg	3	6

1 to 10 of 24Source ClinicalTrials.gov

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Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32335844	DERIVED	PubMed
33687069	DERIVED	PubMed
35939578	DERIVED	PubMed
36069871	DERIVED	PubMed
37148249	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.

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Read this trial from software.

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