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A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy

A legfontosabb adatok

Ki végzi
AbbVie
Hol
Boca Raton, Boston, Brandon, Cromwell, Fresno, Hot Springs, Houston, Indianapolis, Margate, Miami, New York, Omaha, Orange Park, Phoenix, Saint Joseph, San Diego, Scottsdale, St Louis, The Bronx, Thousand Oaks, Troy, Tulsa és Wellington (Egyesült Államok)Mind a 25 helyszín megnézéseMég 7 másik országban, 29 helyszínen
Állapot
Fut, nem toboroz
Fázis
2. fázis
Résztvevők
210 fő vett részt
Kezdés
2021. dec. 28.
Várható befejezés
2027. dec.
A vizsgálat típusa
Beavatkozással járó, 6 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • Lutikizumab
  • Placebo
A regiszteradat frissítve
2026. február 13.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 6 feltétel megnézéseKevesebb

Ki vehet részt

  • A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator
  • A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
  • HS lesions must be present in at least 2 distinct anatomic areas
  • Must have failed anti-TNF treatment for HS
  • To be eligible for the Sub-study, participants must be naïve to biologic therapy for treatment of HS

Ki nem vehet részt

  • History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit

Helyszínek itt: Egyesült Államok

Még 7 másik országban, 29 helyszínen

  • Skin Care Research Boca Raton /ID# 240758Boca Raton, Egyesült ÁllamokNo longer taking part
  • Beth Israel Deaconess Medical Center /ID# 240683Boston, Egyesült ÁllamokNo longer taking part
  • Apex Clinical Trials /ID# 248558Brandon, Egyesült ÁllamokNo longer taking part
  • CCD Research, PLLC /ID# 240728Cromwell, Egyesült ÁllamokNo longer taking part
  • UCSF Fresno /ID# 240903Fresno, Egyesült ÁllamokNo longer taking part
  • Burke Pharmaceutical Research /ID# 240811Hot Springs, Egyesült ÁllamokNo longer taking part
  • Center for Clinical Studies - Houston (Binz) /ID# 240692Houston, Egyesült ÁllamokNo longer taking part
  • Dawes Fretzin, LLC /ID# 240701Indianapolis, Egyesült ÁllamokNo longer taking part
  • GSI Clinical Research, LLC /ID# 240901Margate, Egyesült ÁllamokNo longer taking part
  • Florida International Rsrch cr /ID# 240902Miami, Egyesült ÁllamokNo longer taking part
  • Mount Sinai Doctors Dermatology /ID# 241588New York, Egyesült ÁllamokNo longer taking part
  • Schweiger Dermatology, P.C. /ID# 240900New York, Egyesült ÁllamokNo longer taking part
  • Advanced Dermatology of the Midlands /ID# 249750Omaha, Egyesült ÁllamokNo longer taking part
  • Duplicate_Skin Specialists, PC /ID# 240804Omaha, Egyesült ÁllamokNo longer taking part
  • Park Avenue Dermatology, PA /ID# 240807Orange Park, Egyesült ÁllamokNo longer taking part
  • Medical Dermatology Specialists /ID# 240641Phoenix, Egyesült ÁllamokNo longer taking part
  • MediSearch Clinical Trials /ID# 240810Saint Joseph, Egyesült ÁllamokNo longer taking part
  • Medderm Associates /ID# 240729San Diego, Egyesült ÁllamokNo longer taking part
  • Mayo Clinic - Scottsdale /ID# 241030Scottsdale, Egyesült ÁllamokNo longer taking part
  • Washington University-School of Medicine /ID# 240797St Louis, Egyesült ÁllamokNo longer taking part
  • Montefiore Medical Center /ID# 240853The Bronx, Egyesült ÁllamokNo longer taking part
  • Clinical Trials Research Institute /ID# 240642Thousand Oaks, Egyesült ÁllamokNo longer taking part
  • Revival Research Institute, LLC /ID# 241020Troy, Egyesült ÁllamokNo longer taking part
  • Essential Medical Research, LLC /ID# 241807Tulsa, Egyesült ÁllamokNo longer taking part
  • Duplicate_TruDerm Dermatology of Wellington /ID# 240780Wellington, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy.

A teljes eredeti leírásKevesebb

Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at approximately 20 sites.

In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. There will be an optional Long Term Extension (LTE) for participants who completed Week 52 of the Sub-study and, as confirmed by the investigator, have shown a therapeutic benefit to study drug. Participants would then received lutikizumab using the same assigned dosing regimen as that from Period 2 of the Sub-study for an additional 104 weeks.

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.

A vizsgálat 6 csoportja

  • Main Study: Lutikizumab Dose AA vizsgált kezelés

    Lutikizumab Dose A every week

    Kezelés: Lutikizumab

  • Main Study: Lutikizumab Dose BA vizsgált kezelés

    Lutikizumab Dose B every other week

    Kezelés: Lutikizumab

  • Main Study: Lutikizumab Dose CA vizsgált kezelés

    Lutikizumab Dose C every other week

    Kezelés: Lutikizumab

  • Main Study: PlaceboPlacebo, összehasonlításként

    Placebo every week

    Kezelés: Placebo

  • Sub-study: Group 1A vizsgált kezelés

    Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.

    Kezelés: Lutikizumab

  • Sub-study: Group 2A vizsgált kezelés

    Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.

    Kezelés: Lutikizumab

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab (ABT-981) in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy: Amended Protocol to Include a Lutikizumab Open-Label Sub-study in Subjects Naïve to Biologic Therapy
Publikációk
A regiszteradat frissítve
2026. február 13.