Dovramilast for Erythema Nodosum Leprosum

Not yet recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medicines Development for Global Health

Must not be taking: Thalidomide, Corticosteroids, Immunosuppressives, others

Disqualifiers: Chronic leprosy, Tuberculosis, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental drug called dovramilast to determine if it outperforms current treatments for a leprosy type 2 reaction, also known as erythema nodosum leprosum (ENL). The study compares two doses of dovramilast (100 mg and 150 mg) with standard treatments like prednisolone or thalidomide (in the US) to identify the most effective and safe option. Candidates for this trial include individuals with a confirmed leprosy infection experiencing an acute or recurring type 2 reaction with painful skin bumps. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in leprosy care.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop certain medications before joining the trial. Specifically, you cannot have taken thalidomide, lenalidomide, pomalidomide, systemic corticosteroids, clofazimine (more than 50 mg/day), apremilast, or any other similar treatments within 28 days before starting the trial.

Is there any evidence suggesting that dovramilast is likely to be safe for humans?

Research shows that dovramilast is an experimental drug being tested for safety and effectiveness in treating leprosy type 2 reaction, or erythema nodosum leprosum (ENL). Limited information exists about its safety for humans in this specific use. However, as this is a Phase 2 trial, earlier studies have likely found it to be somewhat safe, indicating previous patients probably tolerated it well. It is important to note that this drug has not been approved for any condition, so its complete safety remains under study. Participation in this study will help researchers learn more about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for leprosy type 2 reaction?

Unlike the standard treatments for erythema nodosum leprosum, which typically include steroids like prednisolone or, in some cases, thalidomide, Dovramilast offers a fresh approach. Researchers are excited about Dovramilast because it brings a new active ingredient to the table, potentially offering a different mechanism of action. This could mean fewer side effects or improved effectiveness. With two different dosages being explored, there's also a chance to optimize its impact for various patient needs.

What evidence suggests that dovramilast might be an effective treatment for erythema nodosum leprosum?

Research has shown that dovramilast is under investigation as a potential treatment for erythema nodosum leprosum (ENL), a complication of leprosy. In this trial, participants will receive either dovramilast or a standard treatment, such as prednisolone or thalidomide (US sites only). Dovramilast blocks an enzyme called phosphodiesterase 4, which causes inflammation. This action might help reduce inflammation associated with ENL. Although limited human data exists specifically for ENL, dovramilast has shown promise in reducing inflammation in other conditions. More research is needed to confirm its effectiveness for ENL, but its mechanism provides a strong basis for potential use. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with leprosy type 2 reaction, also known as erythema nodosum leprosum (ENL). Participants must meet specific health criteria to join. The study excludes individuals who don't fit the inclusion requirements or have conditions that could interfere with the trial's outcomes.

Inclusion Criteria

Provision of written informed consent

Laboratory confirmed previous or current Mycobacterium leprae or Mycobacterium lepromatosis infection

If a woman of reproductive potential, agree to the use of two reliable contraceptive measures

Exclusion Criteria

History of specific diseases or conditions

History of substance abuse or psychiatric illness

Presence of specific laboratory abnormalities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dovramilast (100 mg or 150 mg) or standard of care for 12 weeks to assess efficacy and safety

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including recurrence and exposure metrics

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dovramilast

Trial Overview The study tests dovramilast at doses of 100mg and 150mg against standard treatments like Thalidomide and Prednisolone for ENL. It aims to compare the effectiveness and safety of these options in managing symptoms of this condition.

How Is the Trial Designed?

Group I: Dovramilast 150 mg Experimental Treatment 1 Intervention

Group II: Dovramilast 100 mg Experimental Treatment 1 Intervention

Group III: Standard of care Active Control 2 Interventions

Prednisolone (or thalidomide US sites only)

Who Is Running the Clinical Trial?

Medicines Development for Global Health

Lead Sponsor

Trials

9

Recruited

15,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07172659

NCT07172659 | Efficacy and Safety Study of Dovramilast in ... In this study, an experimental drug called dovramilast is being tested to see how it compares to current treatments for leprosy type 2 reaction.

2. withpower.com withpower.com/trial/phase-2-erythema-nodosum-leprosum-9-2025-93481

Dovramilast for Erythema Nodosum Leprosum In this study, an experimental drug called dovramilast is being tested to see how it compares to current treatments for leprosy type 2 reaction.

3. medicinesdevelopment.com medicinesdevelopment.com/news/mdgh-submits-an-investigational-new-drug-application-for-dovramilast-in-the-treatment-of-leprosy-type-2-reaction

Medicines Development for Global Health MDGH is developing dovramilast, a phosphodiesterase 4 inhibitor, as a potential treatment for leprosy type 2 reaction (erythema nodosum leprosum) ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7413435/

What is New in the Pathogenesis and Management of ... Erythema nodosum leprosum (ENL) is a manifestation of type II lepra reaction, seen in lepromatous or borderline lepromatous leprosy.

5. synapse.patsnap.com synapse.patsnap.com/drug/03c0e6a474724c2c9257c6b5b9f1b5ed

Dovramilast - Drug Targets, Indications, Patents Results: We observed significant reduction in lung viral titer with concomitant reduction in inflammation and fibrotic remodeling in CC-11050 treated hamsters ...

6. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-study-of-dovramilast-in-people-with-leprosy-type-2-reaction

Efficacy and Safety Study of Dovramilast in People With ... In this study, an experimental drug called dovramilast is being tested to see how it compares to current treatments for leprosy type 2 reaction.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04822909

A Study to Evaluate the Efficacy and Safety of Apremilast ... Study period: November 2018 to April 2019 Number of patients to be enrolled in pilot study: 10 This will be a pilot study to assess the efficacy and safety of ...