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A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

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Arlington, Bellaire, Bexley, Birmingham, Boca Raton, Boise, Boston, Bowling Green, Brandon, Bryant, Canton, Charleston, Chicago, Clarkston, Cleveland, Clinton Township, Columbus, Coral Gables, Cypress, Dallas, Dawsonville, Encino, Hialeah, Hollywood, Houston, Indianapolis, Las Vegas, Leawood, Lebanon, Lee's Summit, Los Angeles, Louisville, Margate, Mason, Mayfield Heights, Miami, Mill Creek, Murray, New Haven, New Orleans, New York, Norfolk, North Little Rock, North Palm Beach, Ocala, Philadelphia, Phoenix, Pittsburgh, Plano, Portsmouth, Redwood City, Rocklin, Rolling Meadows, Sacramento, Saint Joseph, San Antonio, Spartanburg, Spokane, Tampa, The Woodlands, Thousand Oaks, Tucson, Tyler, Wellington, Winston-Salem és Worcester (Egyesült Államok)Mind a 73 helyszín megnézése
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3. fázis

Helyszínek itt: Egyesült Államok

  • Arlington Research Center, Inc /ID# 263895Arlington, Egyesült ÁllamokNo longer taking part
  • Bellaire Dermatology Associates /ID# 263850Bellaire, Egyesült ÁllamokNo longer taking part
  • Dermatology of Greater Columbus /ID# 263497Bexley, Egyesült ÁllamokNo longer taking part
  • Cahaba Dermatology & Skin Health Center /ID# 263795Birmingham, Egyesült ÁllamokNo longer taking part
  • Clearlyderm Dermatology - West Boca /ID# 265023Boca Raton, Egyesült ÁllamokNo longer taking part
  • Treasure Valley Medical Research /ID# 263671Boise, Egyesült ÁllamokNo longer taking part
  • Beth Israel Deaconess Medical Center /ID# 263709Boston, Egyesült ÁllamokNo longer taking part
  • Equity Medical, LLC /ID# 268590Bowling Green, Egyesült ÁllamokNo longer taking part
  • Apex Clinical Trials /ID# 263815Brandon, Egyesült ÁllamokNo longer taking part
  • TrueBlue Clinical Research - Brandon /ID# 265041Brandon, Egyesült ÁllamokNo longer taking part
  • Dermatology Trial Associates /ID# 264587Bryant, Egyesült ÁllamokNo longer taking part
  • Hamzavi Dermatology - Canton /ID# 263538Canton, Egyesült ÁllamokNo longer taking part
  • Clinical Research Center of the Carolinas /ID# 263407Charleston, Egyesült ÁllamokNo longer taking part
  • Medical University of South Carolina /ID# 263890Charleston, Egyesült ÁllamokNo longer taking part
  • DeNova Research /ID# 264593Chicago, Egyesült ÁllamokNo longer taking part
  • Northwestern University Feinberg School of Medicine /ID# 265007Chicago, Egyesült ÁllamokNo longer taking part
  • Michigan Center for Medical Research - Clarkston /ID# 263547Clarkston, Egyesült ÁllamokNo longer taking part
  • University Hospitals Cleveland Medical Center /ID# 263600Cleveland, Egyesült ÁllamokNo longer taking part
  • Michigan Center for Skin Care Research /ID# 267228Clinton Township, Egyesült ÁllamokNo longer taking part
  • Centricity Research Columbus Dermatology /ID# 266530Columbus, Egyesült ÁllamokNo longer taking part
  • The Ohio State University Wexner Medical Center - CarePoint East /ID# 263598Columbus, Egyesült ÁllamokNo longer taking part
  • Florida Academic Dermatology Center /ID# 263834Coral Gables, Egyesült ÁllamokNo longer taking part
  • Studies in Dermatology /ID# 263399Cypress, Egyesült ÁllamokNo longer taking part
  • Reveal Research Institute - Dallas /ID# 267233Dallas, Egyesült ÁllamokNo longer taking part
  • Cleaver Medical Group Dermatology /ID# 263845Dawsonville, Egyesült ÁllamokNo longer taking part
  • Private Practice - Dr. Tooraj Raoof /ID# 263756Encino, Egyesült ÁllamokNo longer taking part
  • Direct Helpers Research Center /ID# 278343Hialeah, Egyesült ÁllamokNo longer taking part
  • Skin Care Research - Hollywood /ID# 263805Hollywood, Egyesült ÁllamokNo longer taking part
  • Center for Clinical Studies - Houston - Binz Street /ID# 263378Houston, Egyesült ÁllamokNo longer taking part
  • Dawes Fretzin /ID# 264601Indianapolis, Egyesült ÁllamokNo longer taking part
  • Vivida Dermatology- Flamingo /ID# 263716Las Vegas, Egyesült ÁllamokNo longer taking part
  • Dermatology Partners of Leawood /ID# 263533Leawood, Egyesült ÁllamokNo longer taking part
  • Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713Lebanon, Egyesült ÁllamokNo longer taking part
  • Dermatology and Skin Center of Lees Summit /ID# 263567Lee's Summit, Egyesült ÁllamokNo longer taking part
  • Dermatology Research Associates - Los Angeles /ID# 263765Los Angeles, Egyesült ÁllamokNo longer taking part
  • Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343Louisville, Egyesült ÁllamokNo longer taking part
  • Gsi Clinical Research /ID# 263827Margate, Egyesült ÁllamokNo longer taking part
  • Dermatologists of Southwest Ohio - Mason /ID# 263588Mason, Egyesült ÁllamokNo longer taking part
  • Apex Clinical Research Center /ID# 272787Mayfield Heights, Egyesült ÁllamokNo longer taking part
  • Sullivan Dermatology /ID# 263511Miami, Egyesült ÁllamokNo longer taking part
  • Frontier Dermatology /ID# 278387Mill Creek, Egyesült ÁllamokNo longer taking part
  • University of Utah - Murray /ID# 263818Murray, Egyesült ÁllamokNo longer taking part
  • Yale University School of Medicine /ID# 263695New Haven, Egyesült ÁllamokNo longer taking part
  • Tulane University School of Medicine /ID# 263899New Orleans, Egyesült ÁllamokNo longer taking part
  • Mount Sinai Doctors - Dermatology /ID# 264602New York, Egyesült ÁllamokNo longer taking part
  • Virginia Clinical Research /ID# 264553Norfolk, Egyesült ÁllamokNo longer taking part
  • Arkansas Research Trials /ID# 263901North Little Rock, Egyesült ÁllamokNo longer taking part
  • Vitalia Medical Research /ID# 278321North Palm Beach, Egyesült ÁllamokNo longer taking part
  • Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842Ocala, Egyesült ÁllamokNo longer taking part
  • Dermatology Partners - Philadelphia /ID# 264999Philadelphia, Egyesült ÁllamokNo longer taking part
  • Medical Dermatology Specialists /ID# 263394Phoenix, Egyesült ÁllamokNo longer taking part
  • University of Pittsburgh Medical Center /ID# 264590Pittsburgh, Egyesült ÁllamokNo longer taking part
  • Texas Dermatology Research Center /ID# 264488Plano, Egyesült ÁllamokNo longer taking part
  • StracSkin /ID# 263387Portsmouth, Egyesült ÁllamokNo longer taking part
  • Stanford University School of Medicine - Redwood City /ID# 263711Redwood City, Egyesült ÁllamokNo longer taking part
  • Norcal Clinical Research /ID# 279008Rocklin, Egyesült ÁllamokNo longer taking part
  • Arlington Dermatology /ID# 263410Rolling Meadows, Egyesült ÁllamokNo longer taking part
  • Integrative Skin Science and Research /ID# 264600Sacramento, Egyesült ÁllamokNo longer taking part
  • MediSearch Clinical Trials /ID# 263582Saint Joseph, Egyesült ÁllamokNo longer taking part
  • Texas Dermatology and Laser Specialists /ID# 263778San Antonio, Egyesült ÁllamokNo longer taking part
  • Advanced Dermatology And Cosmetic Surgery - Spartanburg /ID# 267207Spartanburg, Egyesült ÁllamokNo longer taking part
  • Dermatology Specialists of Spokane /ID# 264499Spokane, Egyesült ÁllamokNo longer taking part
  • Advanced Clinical Research Institute - Tampa /ID# 263808Tampa, Egyesült ÁllamokNo longer taking part
  • Alliance Clinical Research of Tampa /ID# 264594Tampa, Egyesült ÁllamokNo longer taking part
  • Skin Care Research - Tampa /ID# 263819Tampa, Egyesült ÁllamokNo longer taking part
  • University of South Florida /ID# 269624Tampa, Egyesült ÁllamokNo longer taking part
  • The Woodlands Dermatology Associates /ID# 266820The Woodlands, Egyesült ÁllamokNo longer taking part
  • Clinical Trials Research Institute /ID# 263743Thousand Oaks, Egyesült ÁllamokNo longer taking part
  • Banner University Medicine Dermatology /ID# 263557Tucson, Egyesült ÁllamokNo longer taking part
  • Dermatology Associates of Tyler /ID# 265002Tyler, Egyesült ÁllamokNo longer taking part
  • TruDerm Research /ID# 278217Wellington, Egyesült ÁllamokNo longer taking part
  • Wake Forest University Health Sciences /ID# 264507Winston-Salem, Egyesült ÁllamokNo longer taking part
  • UMass Memorial Medical Center - Lake Avenue North /ID# 274149Worcester, Egyesült ÁllamokNo longer taking part

A vizsgálat adatai

Ki végzi
AbbVie
Azonosító
NCT06468228EU 2024-510730-40-00
A regiszteradat frissítve
2026. szeptember 2.
Eredeti leírás
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 .A teljes eredeti leírásKevesebb

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

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.

Bevonási feltételek: Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant); Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline; Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline; At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.

Kizáró feltételek: Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; Confirmed positive anti-HIV antibody (HIV Ab) test; Evidence of active tuberculosis or meets tuberculosis exclusionary parameter.

ClinicalTrials.gov NCT06468228 · EU CTIS 2024-510730-40-00