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Trial · NCT06044337

Registered outcomes36

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

ListOutcomeTime frameDescription
PrimaryNumber 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
SecondaryPercentage 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
SecondaryPercentage 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
SecondaryPercentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1Up to 232 weeks
SecondaryPercentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0Up to 232 weeks
SecondaryPercentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) BaselineDay 1 (LTE Baseline) up to 232 weeks
SecondaryPercentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at LTE BaselineDay 1 (LTE Baseline) up to 232 weeks
SecondaryPercentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at LTE BaselineDay 1 (LTE Baseline) up to 232 weeks
SecondaryPercentage 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 BaselineDay 1 (LTE Baseline) up to 232 weeks
Secondary
Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value(Parent Study) Among Participants With CLA IGA R OMC Score of 0 or 1 and at Least 1 Level Improvement From Baseline Value(Parent Study)
Day 1 (LTE Baseline) up to 232 weeks
SecondaryPercentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at LTE BaselineDay 1 (LTE Baseline) up to 232 weeks
SecondaryPercentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From BaselineDay 1 (LTE Baseline) up to 232 weeks
SecondaryPercentage of Participants who Achieve a CLASI A Score of 0 to 3Up to 232 weeks
SecondaryPercentage of Participants who Achieve a CLASI-A Score of 0 to 5Up to 232 weeks
SecondaryPercentage of Participants With a CLASI-A 0 to 3 Response Among CLASI-A 0 to 3 Responders at LTE BaselineDay 1 (LTE Baseline) up to 232 weeks
SecondaryAbsolute Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208Day 1 (Baseline of Parent study) up to 208 weeks
SecondaryPercent Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208Day 1 (Baseline of Parent study) up to 208 weeks
SecondaryAbsolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 208Up to 208 weeks
SecondaryPercent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 208Up to 208 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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