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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
University of Southern California
Los Angeles, California, United States
Harborview Medical Center, University of Washington
Seattle, Washington, United States
Centre de Dépistage de Traitement de la Lèpre et de l'Ulcère de Burulli
Abomey-Calavi, Benin
Chr de Divo
Divo, Côte d’Ivoire
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: 1. 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 2. Standard of care dose increase, switching to or adding another leprosy type 2 reaction treatment
Time frame: 12 weeks
Incidence and severity of adverse events
The incidence and severity of adverse events, changes in vital signs and blood dyscrasias
Time frame: 12 weeks
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.
Time frame: 12 weeks
Skin lesion count changes
• Change from Baseline in skin lesion count up to and including Week 12.
Time frame: 12 weeks
Change from Baseline ENLIST (Erythema Nodosum Leprosum International Study ) severity scale score
Time frame: 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
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Universitas Gadjah Mada
Yogyakarta, Indonesia
Philippine General Hospital, University of the Philippines, Manila
Manila, Philippines
Time frame: from baseline to Week 12
Changes in neuropathy from Baseline grade
Time frame: 12 weeks
Time to resolution
For each individual leprosy type 2 reaction when present at least Grade 1 at Baseline
Time frame: 12 weeks
Proportion of subjects requiring Rescue medication and time to initiation of Rescue medication
Time frame: 12 weeks
Total amount of treatment for leprosy type 2 reaction administered
Time frame: 12 weeks
Recurrences
Recurrence is defined as new signs and symptoms consistent with leprosy type 2 reaction. The number of Recurrence episodes requiring treatment.
Time frame: 48 weeks
Exposure metrics of dovramilast
Area under the curve (AUC)
Time frame: 48 weeks
Exposure metrics of the dovramilast metabolite M15
Area under the curve (AUC)
Time frame: 48 weeks
Skin lesion count changes
• Proportion of Responders at each post-Baseline timepoint.
Time frame: 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.
Time frame: 12 weeks
Exposure metrics of dovramilast
Including AUC, Cmax, and Tmax.
Time frame: 48 weeks
Exposure metrics of dovramilast
Cmax
Time frame: 48 weeks
Exposure metrics of dovramilast
Tmax.
Time frame: 48 weeks