[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medicines Development for Global Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100606215","phase-2-efficacy-and-safety-study-of-dovramilast-in-people-with-leprosy-type-2-reaction-100606215",false,"NCT07172659","Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction","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","Inclusion Criteria:\n\n1. Aged 18 years of age or older.\n2. Provision of written informed consent.\n3. Laboratory confirmed previous or current Mycobacterium leprae or Mycobacterium lepromatosis infection.\n4. Leprosy type 2 reaction meeting the following criteria:\n\n   * Either:\n\n     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).\n   * Presence of at least 10 leprosy type 2 reaction tender papular and\u002For nodular skin lesions (not including scars).\n   * An ENLIST score of at least 9.\n5. 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.\n6. 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.\n\nExclusion Criteria:\n\n1. 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 \\\u003C 28 days.\n2. Receipt of thalidomide, lenalidomide, pomalidomide, systemic corticosteroids, clofazimine (\\> 50 mg\u002Fday), apremilast or any other phosphodiesterase (PDE) 4 inhibitor, or immunosuppressive\u002Fimmunomodulatory treatment within 28 days of Baseline.\n3. Receipt of an investigational agent within 28 days of Baseline or 5 half-lives of the investigational agent (whichever is longer).\n4. Leprosy type 2 reaction with orchitis, uveitis, iritis, or severe neuritis (Grade 3 or greater severe neuritis).\n5. Current diagnosis of leprosy type 1 reaction or Lucio's phenomenon.\n6. Current tuberculosis, malaria, cutaneous or visceral leishmaniasis or other serious bacterial, viral, or parasitic infection at Screening or Baseline.\n7. Active systemic fungal infection requiring or undergoing treatment.\n8. 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.\n9. Other than leprosy type 2 reaction, any other dermatological condition that could, in the opinion of the Investigator, interfere with the study assessments.\n10. Chronic hepatitis B, chronic hepatitis C, or human immunodeficiency virus (HIV) positive.\n11. Pregnant women or breastfeeding mothers.\n12. 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 or use (or planned use) of all strong CYP3A and P-gp inhibitors including ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, ritonavir, cobicistat, diltiazem. Substrates of CYP3A4, CYP2C9, CYP2C19, and P-gp should be used with caution when concomitantly administered with dovramilast.\n13. Known or suspected active substance abuse or a history of substance abuse within 6 months prior to Screening.\n14. 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.\n15. Current diagnosis of depression, and\u002For history of suicide ideation\n16. History of or presence of cardiac disease, including:\n\n    * Clinically significant abnormal electrocardiogram\n    * QTcF \\> 450 msec\n17. Receipt of a vaccination within 7 days of Baseline.\n18. Known or suspected hypersensitivity to: PDE4 inhibitors including dovramilast or apremilast; thalidomide; prednisolone, or; excipients used in the formulation of dovramilast, thalidomide or prednisolone.\n19. Body Mass Index \\\u003C 15 kg\u002Fm\\^2 or \\> 35 kg\u002Fm\\^2.\n20. Unable to, or significant difficulty with, swallowing tablets\u002Fcapsules.\n21. Anemia requiring transfusion.\n22. History of or current pancreatitis.\n23. Known or suspected cirrhosis of the liver.\n24. The following laboratory abnormalities:\n\n    * White blood cells (WBC) \\\u003C 2.5 x 10\\^9\u002F L.\n    * Neutrophils (granulocytes) \\\u003C 1.0 x 10\\^9\u002FL.\n    * Platelets \\\u003C 80 x 10\\^9\u002FL.\n    * Aspartate aminotransferase or alanine aminotransferase \\> 2 times the upper limit of reference range.\n    * Albumin \\\u003C 30 mg\u002FdL.\n    * Bilirubin \\> 2 mg\u002FdL\n    * Calculated creatinine clearance (Cockcroft Gault) \\\u003C 50 milliliter (mL)\u002Fminute.\n    * Lipase ≥ 1.6 times the upper limit\n25. Previous participation in this study\n26. Unwilling, unlikely or unable to comply with all protocol specified assessments, including photographic assessments\n27. Enrolled in another leprosy type 2 reaction treatment study","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26],"Erythema Nodosum Leprosum",[28,29],"Leprosy type 2 reaction","dovramilast","RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":20},"2026-05-25",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"Medicines Development for Global Health","OTHER",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100605196","phase-3-better-options-for-lymphatic-filariasis-treatment-100605196","NCT07159373","Better Options for Lymphatic Filariasis Treatment","Safety and Efficacy Trial of Mass Drug Administration With Moxidectin Versus Ivermectin in Combination With Diethylcarbamazine and Albendazole for Lymphatic Filariasis, Scabies, and Strongyloidiasis in Fiji","BOLT","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent.\n2. Resident in one of the study locations.\n\nExclusion Criteria:\n\nThere are no exclusion criteria to participation in the study.\n\nTreatment Exclusion Criteria:\n\nParticipants are ineligible to receive the treatment regimen allocated to their village if they meet any of the following criteria:\n\n1. Severe illness (any illness that is severe enough to interfere with activities of daily living);\n2. Known or suspected allergy to ivermectin, moxidectin, diethylcarbamazine or albendazole;\n3. Pregnant;\n4. Breastfeeding a baby within 7 days of birth;\n5. Age \\\u003C 4 years for villages randomised to moxidectin, diethylcarbamazine, and albendazole (MoxDA); or\n6. Age \\\u003C 2 years or weight \\\u003C 15 kg for villages randomized to ivermectin, diethylcarbamazine and albendazole (IDA).",true,{"count":53,"type":20},5100,[55],"PHASE3","The goal of this clinical trial is to learn if mass drug administration with moxidectin in combination with diethylcarbamazine, and albendazole (MoxDA) can treat lymphatic filariasis, scabies and strongyloidiasis in children and adults living in communities where these diseases are common. The main questions it aims to answer are:\n\n1. Does MoxDA clear infection in people with lymphatic filariasis ?\n2. Does MoxDA cause any medical problems in infected and uninfected people?\n\nResearchers will compare MoxDA with ivermectin given together with diethylcarbamazine and albendazole (IDA) to see if it works better to clear infection and does not cause any more medical problems.\n\nParticipants will:\n\n1. Be tested to see if they are infected with the parasites that cause lymphatic filariasis, scabies and strongyloidiasis\n2. Take 3 single doses of MoxDA or IDA, 12 months apart\n3. Visit their village centre once or twice in the 1 week after each treatment for safety checkups",[58,59,60],"Lymphatic Filariasis","Scabies","Strongyloidiasis",[62,63,64,65,59,60,66,67,68],"Moxidectin","Ivermectin","Mass drug administration","Lymphatic filariasis","Cluster-randomized","Diethylcarbamazine","Albendazole","NOT_YET_RECRUITING","2025-09-03",{"date":72,"type":34},"2025-09-08",{"date":74,"type":20},"2026-03",{"date":76,"type":20},"2028-06",{"name":40,"class":41},1,""]