Clinical Studies for Dermatology

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Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderate to Severe Hidradenitis Suppurativa
Brief Title: Evaluate Tulisokibart for Hidradenitis Suppurativa
Brief Summary: This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).
For info regarding 2025P000635 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 2, Multi-Center Study Consisting of a Randomized, Placebo-Controlled Period, Followed by an Open-Label Extension Period to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Hidradenitis Suppurativa
Brief Title: Tibulizumab in Adults with Hidradenitis Suppurativa
Brief Summary: The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 16 weeks (Period 1) in adults with hidradenitis suppurativa, followed by a 16-week open-label extension period in which all participants will receive tibulizumab (Period 2)
For info regarding 2025P000578 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
Brief Title: Sonelokimab in Adults with Hidradenitis Suppurativa
Brief Summary: This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.
For info regarding 2025P000575 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)
Brief Title: Phase 3 Topical Ruxolitinib Evaluation in HS
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
For info regarding 2025P000510 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Efficacy And Safety Of Brensocatib In Adults With Moderate To Severe Hidradenitis Suppurativa-The Cedar Study - Ins1007-231
Brief Title: EFFICACY AND SAFETY OF BRENSOCATIB IN ADULTS WITH HS
Brief Summary: The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.
For info regarding 2025P000373 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A randomized, double-blind, double-dummy, placebo-controlled, multicenter, Phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult and adolescent patients with moderate to severe hidradenitis suppurativa (RECHARGE-2)
Brief Title: A randomized, double-blind, double-dummy, placebo-controlled
Brief Summary: The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
For info regarding 2025P000136 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Iii Study To Evaluate The Efficacy And Safety Of Anifrolumab In Adults With Chronic And/Or Subacute Cutaneous Lupus Erythematosus Who Are Refractory And/Or Intolerant To Antimalarial Therapy
Brief Title: ANIFROLUMAB CHRONIC/ SUBACUTE CUTANEOUS LUPUS ERYTHEMATOSUS
Brief Summary: This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
For info regarding 2025P000097 please contact Peter Chien at 617-667-2851 or pchien@bidmc.harvard.edu
 
Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Hidradenitis Suppurativa
Brief Title: Evaluate SBT777101 in Subjects With Hidradenitis Suppurativa
Brief Summary: This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.
For info regarding 2024P000968 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 2, Randomized, Double-blind, Placebocontrolled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients with Moderate to Severe Hidradenitis Suppurativa (LOTUS)
Brief Title: Evaluate AVTX-009 in adults with hidradenitis suppurativa
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
For info regarding 2024P000871 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa
Brief Title: Evaluate Lutikizumab in Adults with Hidradenitis Suppurativa
Brief Summary: Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks. Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks. Participants in the US that complete Periods 1 & 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.
For info regarding 2024P000711 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants with Moderate to Severe Hidradenitis Suppurativa
Brief Title: Evaluate Eltrekibart in Adults with Hidradenitis Suppurativa
Brief Summary: This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.
For info regarding 2024P000158 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy andSafety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe HidradenitisSuppurativa Who Have Failed Anti-TNF Therapy
Brief Title: Abbvie M23-698: Evaluation of Upadacitinib in HS Adults
Brief Summary: Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 300 sites worldwide. Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
For info regarding 2023P000553 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu
 
Title: A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Topical OA-3, a PAR2 Inhibitor, in Adult Healthy Volunteers and Subjects with Atopic Dermatitis and Pruritus
Brief Title: Phase 1a/1b Study Efficacy of Topical OA-3, a PAR2 Inhibitor
Brief Summary: The purpose of this study is to help us understand the safety and the potential effectiveness a new topical study drug called OA-3 hydrogel for the treatment of atopic dermatitis (AD), or eczema. This study will be open to atopic dermatitis patients and healthy patients.
For info regarding 2023P000228 please contact Martina Porter at 617-667-5834 or clears@bidmc.harvard.edu