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Lenalidomide in the Treatment of Mucosal Behçet's Syndrome

ConditionOral Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking Union Medical College Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Intervention with lenalidomideExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

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

A partial response at week 12 was defined as participants with a 50% or more reduction in the number of oral ulcers at week 12

Time frame
12 weeks
2

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

No response at week 12 was defined as all other participants at week 12

Time frame
12 weeks
3

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

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

Time frame
12 weeks
4

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

A partial response at week 12 was defined as participants with a 50% or more reduction in the number of genital ulcers at week 12

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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