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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.
Actively Recruiting
Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.
Actively Recruiting
Lichen planopilaris (LPP) is a type of scarring hair loss caused by inflammation that leads to permanent hair loss and scalp symptoms like itching and burning. Current treatments such as corticosteroids, hydroxychloroquine, and immunosuppressants often do not work well and can cause side effects, leading to frequent changes in therapy. Nemolizumab, a drug that blocks the IL-31 receptor and is approved for other itchy skin diseases, is being studied as a possible new treatment for LPP due to its effects on itch and fibrosis. Participants in this study will receive subcutaneous injections of nemolizumab. This is a noncontrolled, prospective pilot study aimed at evaluating nemolizumab's effects on LPP. The treatment period and specific dosing schedule are not detailed, but participants will be monitored for changes in disease activity and scalp condition over 24 weeks. Throughout the 24 weeks, participants will undergo assessments including the Lichen Planopilaris Activity Index (LPPAI) and Investigator Global Assessment (IGA) score to measure changes in disease severity and scarring alopecia. The study will also track scalp itching intensity. Safety and tolerability will be monitored, and participants must be willing to consent and follow study procedures, including an optional scalp biopsy for research. The overall duration of participation is at least 24 weeks.
Actively Recruiting
Researchers are evaluating the pharmacokinetics and pharmacodynamics (PK/PD) of nemolizumab in adults aged 18 years and older who have chronic pruritus of unknown origin (CPUO). This Phase 2 study aims to understand how nemolizumab is absorbed, distributed, and eliminated in the body while assessing its effect on itch severity over a 16-week treatment period. Participants must have had chronic itching affecting multiple body areas for at least six months without a clear cause and have a history of inadequate itch control with previous treatments. Participants will be randomized in a 4:1 ratio to receive either nemolizumab or a placebo. Dosing is adjusted based on body weight, with those under 90 kilograms receiving 30 mg and those 90 kilograms or above receiving 60 mg via subcutaneous injection. The study includes a 2 to 4-week screening period, followed by 16 weeks of treatment, and then an 8-week follow-up period after the last injection. Overall, participation lasts up to 28 weeks. Participants will undergo various assessments including pruritus severity ratings using the Peak Pruritus Numeric Rating Scale (PP NRS), as well as pharmacokinetic and pharmacodynamic evaluations throughout the study. Safety monitoring and follow-up will continue for 8 weeks post-treatment. Researchers will collect data on drug absorption, distribution, elimination, and its impact on itch symptoms to build a population PK/PD model during the 16-week treatment.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 study compares ruxolitinib cream to a vehicle cream, aiming to see if the treatment helps clear HS symptoms better than a non-active cream. The study focuses on participants with mild to moderate HS who have had the condition for at least six months. Participants will apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily to the affected areas. The study is double-blind and randomized, meaning neither the participants nor the researchers know who receives the active or vehicle cream during the treatment period. Participants must avoid using antibiotics or topical antiseptics on HS areas during the study and extension periods. Throughout the study, participants will be monitored to evaluate the proportion achieving a clinical response, specifically a 75% improvement in HS symptoms by week 16. Safety and treatment effects will be assessed through regular visits, and participants will be observed for any side effects or changes in their condition. The study's total duration includes the treatment and extension phases, with careful adherence to treatment application and restrictions to ensure accurate results.
Actively Recruiting
Warts are common, non-cancerous skin growths caused by the human papillomavirus (HPV), often difficult to treat, especially in children. This research evaluates tirbanibulin ointment as a potential new treatment for pediatric hand warts. The study focuses on children and teens aged 8 to 18 and aims to assess the ointment's safety and effectiveness in this group. Participants will apply tirbanibulin ointment 1% topically to their hand warts. The study is open-label and single-arm, meaning all participants receive the same treatment without a comparison group. Treatment cycles will be completed, and the ointment's effects will be observed. Throughout the study, participants will be monitored for wart resolution two months after completing four or fewer treatment cycles. Researchers will assess treatment safety, monitor adherence, and evaluate the number and size of warts. The total study period includes initial treatment and follow-up to measure outcomes and safety in pediatric patients.