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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05139602
Collaborator
(none)
160
54
4
24.1
3
0.1

Study Details

Study Description

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. 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.

Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. 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.

Participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Lutikizumab
  • Drug: Placebo
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 28, 2021
Anticipated Primary Completion Date :
Oct 22, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lutikizumab Dose A

Lutikizumab Dose A every week

Biological: Lutikizumab
Subcutaneous Injection
Other Names:
  • ABT-981
  • Experimental: Lutikizumab Dose B

    Lutikizumab Dose B every other week

    Biological: Lutikizumab
    Subcutaneous Injection
    Other Names:
  • ABT-981
  • Experimental: Lutikizumab Dose C

    Lutikizumab Dose C every other week

    Biological: Lutikizumab
    Subcutaneous Injection
    Other Names:
  • ABT-981
  • Placebo Comparator: Placebo

    Placebo every week

    Drug: Placebo
    Subcutaneous Injection

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) [Week 16]

      HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 [Week 16]

      NRS 30 is defined as at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain), as assessed by the Patient's Global Assessment (PGA) of Skin Pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Dermatology Specialist /ID# 240641 Phoenix Arizona United States 85006-2722
    2 Mayo Clinic - Scottsdale /ID# 241030 Scottsdale Arizona United States 85259-5452
    3 Burke Pharmaceutical Research /ID# 240811 Hot Springs Arkansas United States 71913-6404
    4 UCSF Fresno /ID# 240903 Fresno California United States 93701-2302
    5 Medderm Associates /ID# 240729 San Diego California United States 92103
    6 California Dermatology Institute /ID# 240642 Thousand Oaks California United States 91320-2130
    7 CCD Research, PLLC /ID# 240728 Cromwell Connecticut United States 06416-1745
    8 Skin Care Research, LLC /ID# 240758 Boca Raton Florida United States 33486-2269
    9 Apex Clinical Trials /ID# 248558 Brandon Florida United States 33511
    10 GSI Clinical Research, LLC /ID# 240901 Margate Florida United States 33063
    11 Florida International Rsrch cr /ID# 240902 Miami Florida United States 33173
    12 Park Avenue Dermatology, PA /ID# 240807 Orange Park Florida United States 32073
    13 TruDerm Dermatology of Wellington /ID# 240780 Wellington Florida United States 33449
    14 Dawes Fretzin, LLC /ID# 240701 Indianapolis Indiana United States 46256
    15 Johns Hopkins University /ID# 240684 Baltimore Maryland United States 21287
    16 Beth Israel Deaconess Medical Center /ID# 240683 Boston Massachusetts United States 02215-5400
    17 A Comprehensive Dermatology Center /ID# 241020 Troy Michigan United States 48084-3536
    18 MediSearch Clinical Trials /ID# 240810 Saint Joseph Missouri United States 64506
    19 Washington University-School of Medicine /ID# 240797 Saint Louis Missouri United States 63110
    20 Skin Specialists, PC /ID# 240804 Omaha Nebraska United States 68144
    21 Psoriasis Treatment Center of Central New Jersey /ID# 240900 East Windsor New Jersey United States 08520
    22 Montefiore Medical Center /ID# 240853 Bronx New York United States 10467
    23 Mount Sinai Doctors Dermatology /ID# 241588 New York New York United States 10029-6504
    24 Essential Medical Research, LLC /ID# 241807 Tulsa Oklahoma United States 74137-2842
    25 Center for Clinical Studies - Houston (Binz) /ID# 240692 Houston Texas United States 77004-8097
    26 Paratus Clinical Research Woden /ID# 240605 Phillip Australian Capital Territory Australia 2606
    27 Holdsworth House Medical Practice /ID# 240911 Darlinghurst New South Wales Australia 2010
    28 Premier Specialist /ID# 241288 Kogarah New South Wales Australia 2217
    29 Veracity Clinical Research /ID# 241096 Woolloongabba Queensland Australia 4102
    30 Beacon Dermatology Inc /ID# 240741 Calgary Alberta Canada T3E 0B2
    31 Wiseman Dermatology Research /ID# 240738 Winnipeg Manitoba Canada R3M 3Z4
    32 Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814 Burlington Ontario Canada L7R 4H9
    33 Dr. S.K. Siddha Medicine Professional Corporation /ID# 247986 Newmarket Ontario Canada L3Y 5G8
    34 Dre Angelique Gagne-Henley M.D. inc. /ID# 240739 Saint-Jerome Quebec Canada J7Z 7E2
    35 Universitaetsklinikum Erlangen /ID# 240872 Erlangen Bayern Germany 91054
    36 Havelklinik /ID# 240874 Berlin Germany 13595
    37 Klinikum Ruhr Univ Bochum /ID# 240870 Bochum Germany 44791
    38 Staedtisches Klinikum Dessau /ID# 240871 Dessau Germany 06847
    39 Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 240873 Hamburg Germany 20246
    40 401 GSNA - 401 Army General Hospital /ID# 242189 Athens Attiki Greece 11525
    41 University General Hospital Attikon /ID# 240371 Athens Attiki Greece 12462
    42 General Hospital Andreas Syggros /ID# 241104 Athens Attiki Greece 16121
    43 Papageorgiou General Hospital Thessaloniki /ID# 240385 Stavroupoli (Thessalonikis) Thessaloniki Greece 55536
    44 General Hospital of Thessaloniki Hippokrateio /ID# 240697 Thessaloniki Greece 54642
    45 Nagoya City University Hospital /ID# 244392 Nagoya shi Aichi Japan 467-8602
    46 Fukuoka University Hospital /ID# 244390 Fukuoka-shi Fukuoka Japan 814-0180
    47 University Hospital Kyoto Prefectural University of Medicine /ID# 244739 Kyoto-shi Kyoto Japan 602-8566
    48 University of the Ryukyus Hospital /ID# 244848 Nakagami-gun Okinawa Japan 903-0215
    49 Kindai University Hospital /ID# 245358 Osakasayama-shi Osaka Japan 589-8511
    50 Cruz-Santana, Carolina, PR /ID# 244514 Carolina Puerto Rico 00985
    51 Hospital de Manises /ID# 240440 Manises Valencia Spain 46940
    52 Hospital Santa Creu i Sant Pau /ID# 240529 Barcelona Spain 08041
    53 Hospital Universitario Virgen de las Nieves /ID# 240429 Granada Spain 18014
    54 Hospital General Universitario Gregorio Maranon /ID# 240396 Madrid Spain 28007

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05139602
    Other Study ID Numbers:
    • M20-262
    • 2020-004108-33
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2022