Lenalidomide in the Treatment of Mucosal Behçet's Syndrome

NCT05449548 | Recruiting

• 1 other identifier: lenalidomide in BS
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Ulcer

Outcome Measures

Primary Outcomes (1)

• The complete remission rate of oral ulcers in subjects after 12 weeks of treatment

  A complete remission at week 12 was defined as participants who were oral ulcer-free at week 12.

  12 weeks

Secondary Outcomes (12)

• Percentage of participants who had an partial response of oral ulcer at Week 12

  12 weeks

• Percentage of participants who had no response of oral ulcer at Week 12

  12 weeks

• Percentage of participants who had a complete response of genital ulcer at Week 12

  12 weeks

• Percentage of participants who had an partial response of genital ulcer at Week 12

  12 weeks

• Percentage of participants who had no response of genital ulcer at Week 12

  12 weeks

Study Arms (1)

Intervention with lenalidomide

EXPERIMENTAL

All subjects will be treated with lenalidomide 10mg/day.

Drug: Lenalidomide 10 mg

Interventions

Lenalidomide 10 mg DRUG

All subjects will be treated with lenalidomide 10mg/day with a regular follow-up of 12 weeks, followed by a 4-week observation after cessation of lenalidomide.

Also known as: Lenalidomide

Intervention with lenalidomide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Oral Ulcer

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wenjie Zheng, M.D.

  Department of Rheumatology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinjing Liu, M.D.

CONTACT

8617810391494; questionmark003@sina.com

Wenjie Zheng, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 8, 2022
• Study Start: April 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)