Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction (NCT07172659) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
United States, Benin, Côte d’Ivoire45 participantsStarted 2026-01
Plain-language summary
Dovramilast has not been approved for leprosy type 2 reaction (erythema nodosum leprosum, ENL) or any other disease anywhere in the world. In this study, an experimental drug called dovramilast is being tested to see how it compares to current treatments for leprosy type 2 reaction. Specifically, this study aims to assess the efficacy of 100mg or 150 mg dovramilast compared with standard treatments (also known as standard of care). This study also aims to assess the safety of two strengths in adults with leprosy type 2 reaction.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged 18 years of age or older.
✓. Provision of written informed consent.
✓. Laboratory confirmed previous or current Mycobacterium leprae or Mycobacterium lepromatosis infection.
✓. Leprosy type 2 reaction meeting the following criteria:
✓. If a woman of reproductive potential, agree to the use of two reliable contraceptive measures (at least one of which is a highly effective form of contraception) from Screening until at least 4 weeks after completion of treatment with dovramilast or standard of care. Refer to Special Considerations for additional information.
✓. If male (including those who have had a successful vasectomy), agree to using a latex condom during any sexual contact with women of reproductive potential from Screening until at least 4 weeks after completion of treatment with dovramilast or standard of care.
Exclusion criteria
✕. Chronic leprosy type 2 reaction, defined as the reaction occurring for 24 weeks or more during which a subject has required treatment either continuously or where any treatment free period had been \< 28 days.
✕. Receipt of thalidomide, lenalidomide, pomalidomide, systemic corticosteroids, clofazimine (\> 50 mg/day), apremilast or any other phosphodiesterase (PDE) 4 inhibitor, or immunosuppressive/immunomodulatory treatment within 28 days of Baseline.
✕. Receipt of an investigational agent within 28 days of Baseline or 5 half-lives of the investigational agent (whichever is longer).
What they're measuring
1
The proportion of dovramilast (100 mg or 150 mg) recipients achieving a 75% improvement in leprosy type 2 reaction skin lesions at week 12
. Leprosy type 2 reaction with orchitis, uveitis, iritis, or severe neuritis (Grade 3 or greater severe neuritis).
✕. Current diagnosis of leprosy type 1 reaction or Lucio's phenomenon.
✕. Current tuberculosis, malaria, cutaneous or visceral leishmaniasis or other serious bacterial, viral, or parasitic infection at Screening or Baseline.
✕. Active systemic fungal infection requiring or undergoing treatment.
✕. Other than leprosy type 2 reaction, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.