Lenalidomide in the Treatment of Mucosal Behçet's Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Jinjing Liu, M.D.
questionmark003@sina.com
8617810391494
Backup
Wenjie Zheng, M.D.
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 42
Treatments
Experimental: Intervention with lenalidomide
All subjects will be treated with lenalidomide 10mg/day.
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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