Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.
To be eligible for the Sub-study, participants must be naïve to biologic therapy for treatment of 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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT05139602

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 53 Locations for this study

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Medical Dermatology Specialists /ID# 240641
Phoenix Arizona, 85006, United States
Mayo Clinic - Scottsdale /ID# 241030
Scottsdale Arizona, 85259, United States
Burke Pharmaceutical Research /ID# 240811
Hot Springs Arkansas, 71913, United States
UCSF Fresno /ID# 240903
Fresno California, 93701, United States
Medderm Associates /ID# 240729
San Diego California, 92103, United States
Clinical Trials Research Institute /ID# 240642
Thousand Oaks California, 91320, United States
CCD Research, PLLC /ID# 240728
Cromwell Connecticut, 06416, United States
Skin Care Research - Boca Raton /ID# 240758
Boca Raton Florida, 33486, United States
Apex Clinical Trials /ID# 248558
Brandon Florida, 33511, United States
GSI Clinical Research, LLC /ID# 240901
Margate Florida, 33063, United States
Florida International Rsrch cr /ID# 240902
Miami Florida, 33173, United States
Park Avenue Dermatology, PA /ID# 240807
Orange Park Florida, 32073, United States
TruDerm Dermatology of Wellington /ID# 240780
Wellington Florida, 33449, United States
Dawes Fretzin, LLC /ID# 240701
Indianapolis Indiana, 46256, United States
Beth Israel Deaconess Medical Center /ID# 240683
Boston Massachusetts, 02215, United States
Revival Research Institute, LLC /ID# 241020
Troy Michigan, 48084, United States
MediSearch Clinical Trials /ID# 240810
Saint Joseph Missouri, 64506, United States
Washington University-School of Medicine /ID# 240797
Saint Louis Missouri, 63110, United States
Advanced Dermatology of the Midlands /ID# 249750
Omaha Nebraska, 68144, United States
Skin Specialists, PC /ID# 240804
Omaha Nebraska, 68144, United States
Psoriasis Treatment Center of Central New Jersey /ID# 240900
East Windsor New Jersey, 08520, United States
Montefiore Medical Center /ID# 240853
Bronx New York, 10467, United States
Mount Sinai Doctors Dermatology /ID# 241588
New York New York, 10029, United States
Essential Medical Research, LLC /ID# 241807
Tulsa Oklahoma, 74137, United States
Center for Clinical Studies - Houston (Binz) /ID# 240692
Houston Texas, 77004, United States
Duplicate_Paratus Clinical Research Woden /ID# 240605
Phillip Australian Capital Territory, 2606, Australia
Holdsworth House Medical Practice /ID# 240911
Darlinghurst New South Wales, 2010, Australia
Premier Specialist /ID# 241288
Kogarah New South Wales, 2217, Australia
Veracity Clinical Research /ID# 241096
Woolloongabba Queensland, 4102, Australia
Beacon Dermatology Inc /ID# 240741
Calgary Alberta, T3A 2, Canada
Wiseman Dermatology Research /ID# 240738
Winnipeg Manitoba, R3M 3, Canada
Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814
Hamilton Ontario, L8L 3, Canada
SKDS Research /ID# 247986
Newmarket Ontario, L3Y 5, Canada
Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
Saint-Jerome Quebec, J7Z 7, Canada
Universitaetsklinikum Erlangen /ID# 240872
Erlangen Bayern, 91054, Germany
Havelklinik /ID# 240874
Berlin , 13595, Germany
Klinikum Ruhr Univ Bochum /ID# 240870
Bochum , 44791, Germany
Staedtisches Klinikum Dessau /ID# 240871
Dessau , 06847, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 240873
Hamburg , 20246, Germany
401 GSNA - 401 Army General Hospital /ID# 242189
Athens Attiki, 11527, Greece
University General Hospital Attikon /ID# 240371
Athens Attiki, 12462, Greece
General Hospital Andreas Syggros /ID# 241104
Athens Attiki, 16121, Greece
Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385
Stavroupoli (Thessalonikis) Thessaloniki, 55536, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 240697
Thessaloniki , 54642, Greece
Nagoya City University Hospital /ID# 244392
Nagoya shi Aichi, 467-8, Japan
Fukuoka University Hospital /ID# 244390
Fukuoka-shi Fukuoka, 814-0, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 244739
Kyoto-shi Kyoto, 602-8, Japan
University of the Ryukyus Hospital /ID# 244848
Nakagami-gun Okinawa, 903-0, Japan
Kindai University Hospital /ID# 245358
Osakasayama-shi Osaka, 589-8, Japan
Alma M. Cruz Santana, MD-Private practice /ID# 244514
Carolina , 00985, Puerto Rico
Hospital de Manises /ID# 240440
Manises Valencia, 46940, Spain
Hospital Santa Creu i Sant Pau /ID# 240529
Barcelona , 08041, Spain
Hospital Universitario Virgen de las Nieves /ID# 240429
Granada , 18014, Spain
Hospital General Universitario Gregorio Maranon /ID# 240396
Madrid , 28007, Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

200

Study ID:

NCT05139602

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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