Erythema Nodosum LeprosumPhase 2NCT07172659
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
A Phase 2 study testing Dovramilast, Prednisolone and Thalidomide in people with Erythema Nodosum Leprosum, run by Medicines Development for Global Health at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythema Nodosum Leprosum
- What is being tested?
- Dovramilast, Prednisolone and Thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 15 Sep 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
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- 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 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.
Who cannot join
- 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).
- 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.
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- 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.
- 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 (including grapefruit) known to affect activity of the cytochrome (CYP)3A4 enzyme; of all strong CYP3A and P-gp inhibitors including ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, ritonavir, cobicistat, diltiazem; and sensitive substrates of CYP3A4, CYP2C9, CYP2C19, and P-gp. Other CYP3A4, CYP2C9, CYP2C19, and P-gp non-sensitive substrates should be used with caution when concomitantly administered with dovramilast.
- 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 < 15 kg/m^2 or > 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
Trial locations and contacts
6 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 6 countries
United States1 site, 1 recruiting
- Recruiting
Harborview Medical Center, University of Washington
Seattle, Washington, 98104
Dr Jason Simmons, MD, PhD, 206-744-5463, jasonds@uw.edu
Benin1 site, 1 recruiting
- Not yet recruiting
Centre de Dépistage de Traitement de la Lèpre et de l'Ulcère de Burulli
Abomey-Calavi
Indonesia1 site, 1 recruiting
- Recruiting
Universitas Gadjah Mada
Yogyakarta
Shinta Trilaksmi Dewi, MD, PhD, +6282137381045, shinta.trilaksmi.d@ugm.ac.id
Madagascar1 site, 1 recruiting
- Not yet recruiting
Programme national lutte contre la lèpre
Tôlanaro
Andrinamira Randrianantoandro, andriamiradomoina@gmail.com
Philippines1 site, 1 recruiting
- Recruiting
Philippine General Hospital, University of the Philippines, Manila
Manila
Dofitas, 63285548400, bldofitas@up.edu.ph
About this study
Official title: A 12-week, Open-label, Randomized, Standard of Care Controlled, Dose-ranging Safety and Efficacy Study of Dovramilast in People With Moderate to Severe Acute or Recurrent Leprosy Type 2 Reaction
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.
- Conditions
- Erythema Nodosum Leprosum
- Being tested
- Dovramilast, Prednisolone, Thalidomide
- Keywords
- Leprosy type 2 reaction, dovramilast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DovramilastDrug
Dovramilast
PrednisoloneDrug
Standard of care
ThalidomideDrug
Standard of care (US only)
| Study group | Role | What they receive |
|---|---|---|
| Dovramilast 100 mg | Experimental | Not described Receives: Drug: Dovramilast |
| Dovramilast 150 mg | Experimental | Not described Receives: Drug: Dovramilast |
| Standard of care | Active comparator | Prednisolone (or thalidomide US sites only) Receives: Drug: Prednisolone; Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of dovramilast (100 mg or 150 mg) recipients achieving a 75% improvement in leprosy type 2 reaction skin lesions at week 12
The proportion of subjects achieving a reduction of leprosy type 2 reaction skin lesion count of at least 75% from Baseline at Week 12 without the need for rescue.
Rescue is defined as:
- A change from dovramilast at any dose to standard of care or dose maintenance beyond taper time points defined in standard of care treatment guidelines (and specified in this protocol), or
- Standard of care dose increase, switching to or adding another leprosy type 2 reaction treatment
Measured: 12 weeks
Incidence and severity of adverse events
The incidence and severity of adverse events, changes in vital signs and blood dyscrasias
Measured: 12 weeks
Secondary outcomes (16)
Resolution of fever to ≤ Grade 1
Proportion of subjects with resolution of fever to ≤ Grade 1 among the subgroup of subjects with fever present at Baseline at Grade 2 or greater.
Measured: 12 weeks
Skin lesion count changes
- Change from Baseline in skin lesion count up to and including Week 12.
Measured: 12 weeks
Change from Baseline ENLIST (Erythema Nodosum Leprosum International Study ) severity scale score
Measured: At each post Baseline time point
Change from Baseline of each of the following parameters when present at Baseline at Grade 2 or greater
- Leprosy type 2 reaction lesions with respect to: number, inflammation, and extent
- Neuritis
- Pain:
- Fever
- Peripheral edema with respect to location and severity
- Inflammation of joints and/or digits
- Lymphadenopathy
Measured: from baseline to Week 12
Changes in neuropathy from Baseline grade
Measured: 12 weeks
Time to resolution
For each individual leprosy type 2 reaction when present at least Grade 1 at Baseline
Measured: 12 weeks
Proportion of subjects requiring Rescue medication and time to initiation of Rescue medication
Measured: 12 weeks
Total amount of treatment for leprosy type 2 reaction administered
Measured: 12 weeks
Recurrences
Recurrence is defined as new signs and symptoms consistent with leprosy type 2 reaction. The number of Recurrence episodes requiring treatment.
Measured: 48 weeks
Exposure metrics of dovramilast
Area under the curve (AUC)
Measured: 48 weeks
Exposure metrics of the dovramilast metabolite M15
Area under the curve (AUC)
Measured: 48 weeks
Skin lesion count changes
- Proportion of Responders at each post-Baseline timepoint.
Measured: 12 weeks
Skin lesion count changes
Proportion of subjects achieving a reduction of leprosy type 2 reaction skin lesion count from Baseline of 50%, 90% and 100% without Rescue at Week 12.
Measured: 12 weeks
Exposure metrics of dovramilast
Including AUC, Cmax, and Tmax.
Measured: 48 weeks
Exposure metrics of dovramilast
Cmax
Measured: 48 weeks
Exposure metrics of dovramilast
Tmax.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Sep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythema Nodosum LeprosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicines Development for Global Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172659
- Sponsor's protocol ID
- MDGH-DOV-2001
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided