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Tests treatment safety and results for Erythema Nodosum Leprosum
Official title Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
ClinicalTrials.gov ID: NCT07172659
What this study is testing
What is Dovramilast?
Dovramilast is an investigational medicine, being studied as a potential treatment for erythema nodosum leprosum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
- Either: i. Acute (first episode and no treatment initiated) or ii. Recurrent (at least one further episode occurring 28 days or more after withdrawal...
You likely can't join if
- Chronic leprosy type 2 reaction, defined as the reaction occurring for 24 weeks or more during which a subject has required treatment either...
- Receipt of thalidomide, lenalidomide, pomalidomide, systemic corticosteroids, clofazimine (\> 50 mg/day), apremilast or any other phosphodiesterase...
- Receipt of an investigational agent within 28 days of Baseline or 5 half-lives of the investigational agent (whichever is longer).
- 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.
See the full eligibility 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:
- Either: i. Acute (first episode and no treatment initiated) or ii. Recurrent (at least one further episode occurring 28 days or more after withdrawal of leprosy type 2 reaction treatment).
- Presence of at least 10 leprosy type 2 reaction tender papular and/or nodular skin lesions (not including scars).
- An ENLIST score of at least 9.
- 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...
- 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...
- 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...
- Receipt of an investigational agent within 28 days of Baseline or 5 half-lives of the investigational agent (whichever is longer).
- 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...
- Other than leprosy type 2 reaction, any other dermatological condition that could, in the opinion of the Investigator, interfere with the study assessments.
- Chronic hepatitis B, chronic hepatitis C, or human immunodeficiency virus (HIV) positive.
- Pregnant women or breastfeeding mothers.
- Use (or planned use) of antimetabolites or alkylating agents, rifampin use more frequent than monthly, phenobarbital, carbamazepine, phenytoin, traditional or herbal preparations (including St. John's wort), foods...
- Known or suspected active substance abuse or a history of substance abuse within 6 months prior to Screening.
- Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or Randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- Current diagnosis of depression, and/or history of suicide ideation
- History of or presence of cardiac disease, including:
- Clinically significant abnormal electrocardiogram
- QTcF \> 450 msec
- Receipt of a vaccination within 7 days of Baseline.
- Known or suspected hypersensitivity to: PDE4 inhibitors including dovramilast or apremilast; thalidomide; prednisolone, or; excipients used in the formulation of dovramilast, thalidomide or prednisolone.
- Body Mass Index \ 35 kg/m\^2.
- Unable to, or significant difficulty with, swallowing tablets/capsules.
- Anemia requiring transfusion.
- History of or current pancreatitis.
- Known or suspected cirrhosis of the liver.
- The following laboratory abnormalities:
- White blood cells (WBC) \< 2.5 x 10\^9/ L.
- Neutrophils (granulocytes) \< 1.0 x 10\^9/L.
- Platelets \< 80 x 10\^9/L.
- Aspartate aminotransferase or alanine aminotransferase \> 2 times the upper limit of reference range.
- Albumin \< 30 mg/dL.
- Bilirubin \> 2 mg/dL
- Calculated creatinine clearance (Cockcroft Gault) \< 50 milliliter (mL)/minute.
- Lipase ≥ 1.6 times the upper limit
- Previous participation in this study
- Unwilling, unlikely or unable to comply with all protocol specified assessments, including photographic assessments
- Enrolled in another leprosy type 2 reaction treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
- Abomey-Calavi, Benin
- Divo, Côte d’Ivoire
- Yogyakarta, Indonesia
- Tôlanaro, Madagascar
- Manila, Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States; Abomey-Calavi, Benin; Divo, Côte d’Ivoire; Yogyakarta, Indonesia; Tôlanaro, Madagascar; Manila, Philippines. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.