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
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.
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.
- 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.
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There are 53 Locations for this study
Phoenix Arizona, 85006, United States
Scottsdale Arizona, 85259, United States
Hot Springs Arkansas, 71913, United States
Fresno California, 93701, United States
San Diego California, 92103, United States
Thousand Oaks California, 91320, United States
Cromwell Connecticut, 06416, United States
Boca Raton Florida, 33486, United States
Brandon Florida, 33511, United States
Margate Florida, 33063, United States
Miami Florida, 33173, United States
Orange Park Florida, 32073, United States
Wellington Florida, 33449, United States
Indianapolis Indiana, 46256, United States
Boston Massachusetts, 02215, United States
Troy Michigan, 48084, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68144, United States
Omaha Nebraska, 68144, United States
East Windsor New Jersey, 08520, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
Tulsa Oklahoma, 74137, United States
Houston Texas, 77004, United States
Phillip Australian Capital Territory, 2606, Australia
Darlinghurst New South Wales, 2010, Australia
Kogarah New South Wales, 2217, Australia
Woolloongabba Queensland, 4102, Australia
Calgary Alberta, T3E 0, Canada
Winnipeg Manitoba, R3M 3, Canada
Burlington Ontario, L7R 4, Canada
Newmarket Ontario, L3Y 5, Canada
Saint-Jerome Quebec, J7Z 7, Canada
Erlangen Bayern, 91054, Germany
Berlin , 13595, Germany
Bochum , 44791, Germany
Dessau , 06847, Germany
Hamburg , 20246, Germany
Athens Attiki, 11527, Greece
Athens Attiki, 12462, Greece
Athens Attiki, 16121, Greece
Stavroupoli (Thessalonikis) Thessaloniki, 55536, Greece
Thessaloniki , 54642, Greece
Nagoya shi Aichi, 467-8, Japan
Fukuoka-shi Fukuoka, 814-0, Japan
Kyoto-shi Kyoto, 602-8, Japan
Nakagami-gun Okinawa, 903-0, Japan
Osakasayama-shi Osaka, 589-8, Japan
Carolina , 00985, Puerto Rico
Manises Valencia, 46940, Spain
Barcelona , 08041, Spain
Granada , 18014, Spain
Madrid , 28007, Spain
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