Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus. (NCT03958955) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus.
Stopped: Terminated due to recruitment challenges.
United States27 participantsStarted 2019-07-09
Plain-language summary
This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* Histopathological findings (current or previous) consistent with clinical diagnosis of DLE.
* Unequivocal clinical diagnosis of 2 active DLE target lesions that were \<6 months old and amenable for clinical evaluation. This included lesions located on the scalp if they fulfilled all lesion-specific eligibility criteria.
* Target lesion IGA score of at least moderate severity (≥3) at screening and baseline.
* Target lesion erythema score ≥2 at screening and baseline.
Main Exclusion Criteria:
* Target lesion dyspigmentation score of 2 at screening or baseline.
* Target lesion scarring/atrophy score of 2 at screening or baseline.
* Target lesion scarring alopecia score of \>0 in scalp lesions at screening or baseline.
* Medical history of systemic lupus erythematosus (SLE) with clinically significant organ involvement (American College of Rheumatology SLE classification criteria no. 6 to 9) including SLE-related pleuritis or pericarditis (by clinical evaluation and electrocardiogram), and neurologic, renal, and/or other major SLE-related organ system involvement. SLE joint involvement was acceptable.
* Subjects with unstable or significant SLE disease activity findings that would, by its progressive nature and/or severity, interfere with the trial evaluation, completion, and/or procedures per the investigator's discretion.
* Other skin conditions at screening or baseline that would interfere with the evaluation of DLE.
* Immunosuppressive/immunomodu…
What they're measuring
1
Target Lesions With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 6.