Actively Recruiting
12-Week Study Comparing Two Doses of Dovramilast With Standard Treatment for Moderate to Severe Leprosy Type 2 Reaction in Adults
Led by Medicines Development for Global Health · Updated on 2026-05-26
45
Participants Needed
6
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying dovramilast, an experimental drug not yet approved for leprosy type 2 reaction erythema nodosum leprosum, ENL, to compare its effects with current standard treatments. The study focuses on adults with moderate to severe acute or recurrent leprosy type 2 reaction to evaluate the safety and efficacy of two doses of dovramilast, 100 mg and 150 mg. This Phase 2 trial aims to understand how well these doses improve skin lesions and assess any adverse effects. Participants will be randomly assigned to receive either 100 mg or 150 mg of dovramilast or standard care, which includes prednisolone or thalidomide in US sites only. The treatment period lasts 12 weeks, during which the responses to these interventions are monitored. The study is open-label, meaning both researchers and participants know which treatment is given. The trial includes a dose-ranging design to evaluate different strengths of dovramilast. During the 12-week trial, participants will undergo assessments including skin lesion evaluations, fever resolution, and neuropathy changes. Researchers will use the ENLIST severity scale and monitor the need for rescue medications. Safety is closely monitored by tracking adverse events. Additional follow-up up to 48 weeks will assess recurrences and drug exposure. Participants will be regularly evaluated with laboratory tests and photographic assessments to measure outcomes and ensure adherence.
CONDITIONS
Brief Title
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years of age or older.
- Written informed consent provided.
- Laboratory confirmed previous or current Mycobacterium leprae or Mycobacterium lepromatosis infection.
- Leprosy type 2 reaction that is either acute (first episode without prior treatment) or recurrent (at least one further episode 28 days or more after stopping treatment).
- Presence of at least 10 tender papular and/or nodular skin lesions (excluding scars).
- ENLIST severity score of at least 9.
- Women of reproductive potential agree to use two reliable contraceptive methods from screening until 4 weeks after treatment.
- Males agree to use latex condoms during sexual contact with women of reproductive potential from screening until 4 weeks after treatment.
You will not qualify if you...
- Chronic leprosy type 2 reaction lasting 24 weeks or more with continuous or nearly continuous treatment.
- Use of thalidomide, lenalidomide, pomalidomide, systemic corticosteroids, clofazimine (>50 mg/day), apremilast, other PDE4 inhibitors, or immunosuppressive treatments within 28 days before baseline.
- Use of investigational agents within 28 days or 5 half-lives before baseline.
- Leprosy type 2 reaction with orchitis, uveitis, iritis, or severe neuritis (Grade 3 or higher).
- Current diagnosis of leprosy type 1 reaction or Lucio's phenomenon.
- Active tuberculosis, malaria, leishmaniasis, or other serious infections at screening or baseline.
- Active systemic fungal infection requiring treatment.
- Significant uncontrolled major diseases other than leprosy type 2 reaction.
- Other dermatological conditions that could interfere with study assessments.
- Chronic hepatitis B, chronic hepatitis C, or HIV positive.
- Pregnant or breastfeeding women.
- Use or planned use of certain medications or substances affecting CYP3A4 enzyme or P-gp.
- History or suspicion of substance abuse within 6 months prior to screening.
- History of suicide attempt or major psychiatric illness requiring hospitalization within 3 years.
- Current diagnosis of depression or history of suicidal ideation.
- History or presence of cardiac disease including abnormal ECG or QTcF > 450 msec.
- Vaccination within 7 days before baseline.
- Hypersensitivity to PDE4 inhibitors, thalidomide, prednisolone, or formulation excipients.
- Body Mass Index below 15 or above 35 kg/m2.
- Difficulty swallowing tablets or capsules.
- Anemia requiring transfusion.
- History or current pancreatitis.
- Known or suspected liver cirrhosis.
- Specific laboratory abnormalities including low white blood cells, neutrophils, platelets, elevated liver enzymes, low albumin, high bilirubin, low creatinine clearance, or high lipase.
- Previous participation in this study.
- Unwillingness or inability to comply with protocol assessments including photographic assessments.
- Enrollment in another leprosy type 2 reaction treatment study.
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