Lenalidomide in the Treatment of Mucosal Behçet's Syndrome (NCT05449548) | Clinical Trial Compass
RecruitingNot Applicable
Lenalidomide in the Treatment of Mucosal Behçet's Syndrome
China42 participantsStarted 2023-04-01
Plain-language summary
The study is to evaluate the efficacy and safety of lenalidomide in the treatment of oral ulcers in adult patients with refractory mucosal Behcet's syndrome.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients that can understand and voluntarily sign an informed consent document prior to the study;
* Male and female subjects ≥ 18 years and ≤ 65 years of age at the time of signing the informed consent document.
* Fulfilling the ICBD (International Conference on Behcet's Disease) criteria(2013);
* Presented with active mucosal lesions: Subjects must have at least 1 oral ulcer within 4 weeks after the screening visit and at least 2 oral ulcers on the day of enrollment; subjects may be with or without genital ulcers and (or) skin lesions.
* Refractory mucosal lesions: Subjects must experience at least 2 relapses of oral ulcers during 3 consecutive months of conventional treatment with corticosteroids and(or) immunosuppressants.
* Without major organ involvement, including active gastrointestinal, ocular, nervous system, and major vessel involvement; previous major organ involvement is allowed if it occurred at least 1 year prior to the screening visit and is not active at the time of enrollment.; subjects with arthritis are permitted.
Exclusion Criteria: The presence of any of the following will exclude a subject from the study enrollment.
Exclusion Criteria:
* Pregnant women or breastfeeding mothers, Male and female patients with recent fertility requirements.
* Skin and mucosal lesions should exclude erythema multiforme, syphilis, Sweet disease, Stevens-Johnson syndrome, acne vulgaris, herpes simplex infection, periodic granulocytopenia, and acquire…
What they're measuring
1
The complete remission rate of oral ulcers in subjects after 12 weeks of treatment