Using lenalidomide to treat oral ulcers in Behçet's syndrome

Lenalidomide in the Treatment of Mucosal Behçet's Syndrome

This study is testing if lenalidomide can help adults with Behçet's syndrome get rid of their painful oral ulcers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: infliximab, adalimumab, golimumab, certolizumab, tocilizumab, secukinumab, tofacitinib, baricitinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05449548 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of lenalidomide in treating oral ulcers in adult patients with refractory mucosal Behçet's syndrome. Behçet's syndrome is a systemic vasculitis characterized by recurrent oral and genital ulcers, among other symptoms. The study is a single-center, prospective, open-label, single-arm design, focusing on the rate of complete remission of oral ulcers after 12 weeks of treatment with lenalidomide at a dosage of 10 mg per day. Secondary endpoints include partial remission rates and safety assessments related to adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with refractory mucosal Behçet's syndrome who have experienced multiple relapses of oral ulcers despite conventional treatments.

Not a fit: Patients with major organ involvement or those who do not meet the criteria for refractory mucosal lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from refractory oral ulcers associated with Behçet's syndrome.

How similar studies have performed: While there have been case reports and preliminary studies on lenalidomide for this condition, clinical trials specifically evaluating its efficacy in refractory mucosal Behçet's syndrome are lacking.

Eligibility criteria

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 acquired immunodeficiency.
* Subjects with Behçet's syndrome-related active major organ involvement that requires aggressive immunosuppressive therapy, including active gastrointestinal, ocular, nervous system, and major vessel involvement.
* Severe Concomitant disease: including heart failure(≥level Ⅲ, NYHA), respiratory failure, renal insufficiency (Serum creatinine ≥ 1.5 mg/dL ), hepatic insufficiency(Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 2 X ULN.), myelosuppression(WBC\<3.0×109/L or N\<1.5×109/L, HGB≤85g/L, PLT\<100×109/L), peripheral neuropathy.
* Acute severe infections such as sepsis and cellulitis, active hepatitis B or C virus infection, active tuberculosis, and history of a positive test for, or any clinical suspicion of, human immunodeficiency virus (HIV).
* Patients with malignancy, or any history of malignancy within the 5 years prior to the screening phase, risk factors for myocardial infarction (including a history of thrombosis), or hypercoagulability.
* History of use of lenalidomide or thalidomide within 1 month before enrollment.
* Patients with allergies or contraindications to lenalidomide or thalidomide.
* Having received concomitant immune-modulating therapy or small molecule drugs. At least 5 terminal half-lives for all biologics, including, but not limited to, those listed below; within:

Ten days prior to the day of enrollment for tofacitinib and baricitinib Four weeks prior to the day of enrollment for etanercept Eight weeks prior to the day of enrollment for infliximab Ten weeks prior to the day of enrollment for adalimumab, golimumab, certolizumab, abatacept, and tocilizumab Six months prior to the day of enrollment for secukinumab

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Wenjie Zheng, M.D. — Department of Rheumatology, Peking Union Medical College Hospital
• Study coordinator: Jinjing Liu, M.D.

Conditions Oral Ulcer