Trial · NCT06044337
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
NCT06044337, Phase 3, Enrolling by invitation, Biogen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus. Trials, record NCT06044337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06044337
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
- NCT number
- NCT06044337
- Status
- Enrolling by invitation
- Phases
- Phase 3
- Enrollment
- 306 participants, estimated
- Lead sponsor
- Biogen
- Conditions
- Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
- Interventions
- BIIB059 (litifilimab)
- First posted
- 2023-09-21
- Last updated
- 2026-08-04
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 232 weeks | |
| Secondary | Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) | Up to 232 weeks | |
| Secondary | Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) | Up to 232 weeks | |
| Secondary | Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) | Up to 232 weeks | |
| Secondary | Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 | Up to 232 weeks | |
| Secondary | Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 | Up to 232 weeks | |
| Secondary | Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) Baseline | Day 1 (LTE Baseline) up to 232 weeks | |
| Secondary | Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at LTE Baseline | Day 1 (LTE Baseline) up to 232 weeks | |
| Secondary | Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at LTE Baseline | Day 1 (LTE Baseline) up to 232 weeks | |
| Secondary | Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 Among Participants With a CLA-IGA-R Erythema Score of 0 or 1 at LTE Baseline | Day 1 (LTE Baseline) up to 232 weeks |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT06044337
GET https://conductscience.org/api/trials/v1/NCT06044337/registered?page=2