Trial · NCT07355218
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline | At Week 24 | |
| Secondary | Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response | At Week 24 | A BICLA response is defined as British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) -improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and less than or equal to \[\<=\] 1 new B.); Here, score A ("Active"): Severely active disease; score B ("Beware"): Moderately active disease; score C ("Contentment"): Mild stable disease; score D ("Discount"): Inactive now but previously active; -no worsening in disease activity (no new BILAG 2004 A scores and \<= 1 new B score); -no worsening of total Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score from Baseline; -no significant deterioration (less than \[\<\] 10% worsening) in visual analog Physician's Global Assessment (PGA) and -no treatment failure i.e. protocol-prohibited medications as determined by Endpoint Adjudication Committee (EAC) or premature discontinuation from study treatment). |
| Secondary | Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) | From Day 1 to Week 24 | |
| Secondary | Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters | From Day 1 to Week 24 | |
| Secondary | Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24 | At Week 24 | CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity. |
| Secondary | Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline | At Weeks 4 and 24 | |
| Secondary | Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction | Day 1 up to Week 12 and thereafter upto Week 24 | Clinically meaningful CS reduction, is defined as reduction of daily prednisone-equivalent dose from \>= 10 milligrams (mg) at Day 1 to \<= 5 mg by the Week 12 visit and sustained through Week 24. |
| Secondary | Change from Baseline in Worst Itch Numeric Rating Scale (NRS) Score at Week 24 | Baseline and at Week 24 | The Worst Itch NRS is a self-rated single item scale designed for assessing worst itch in the past 7 days. The scale utilizes 11-point NRS, scored from of 0 (no itch) to 10 (worst imaginable itch). |
| Secondary | Change from Baseline in CLASI-A Erythema at Week 24 | Baseline and at Week 24 | CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity. |
| Secondary | Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24 | Baseline and at Week 24 | CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity. |
| Secondary | Change from Baseline in CLASI-A Alopecia at Week 24 | Baseline and at Week 24 | CLASI-A assesses the signs of CLE disease activity including erythema, scale, and hypertrophy, active alopecia, and mucous membrane disease, Scores range from 0 to 70 points for CLASI-A score. Mild, moderate, and severe disease corresponds with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity. |
| Secondary | Percentage of Participants With a Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R OMC) Score of 0 or 1 and at Least a 1-Point Reduction at Week 24 | At Week 24 | The CLA-IGA-R is assessed by the investigator, who assigns rater to assign scores to 3 individual domains (e.g. erythema, other morphologic characteristics - OMC \[scales, edema)/infiltration and secondary change (vesicles, erosion, crusting)\] and follicular activity). Clinicians assess the severity of the first 2 domains of erythema and OMC from 0 (Clear) to 4 (Severe); they assess the severity of the third domain of follicular activity as "absent" or "present." Higher scores indicate more disease activity. |
| Secondary | Percentage of Participants with BILAG Moderate to Severe Flares | up to Week 24 | |
| Secondary | Time to First Moderate/Severe BILAG Flare | Day 1 through Week 24 | Median time to first moderate or severe BILAG Flare will be calculated. |
| Secondary | Percentage of Participants with Corticosteroid (CS) reduction of Daily Prednisone Equivalent Dose | Day 1 up to 24 weeks | CS reduction is defined as of daily prednisone-equivalent dose from \>= 10 milligrams per day (mg/day) at Day 1 to \<= 5 mg/day and sustained for 12 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07355218/registered