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
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 |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lutikizumab Dose A Lutikizumab Dose A every week |
Biological: Lutikizumab
Subcutaneous Injection
Other Names:
|
Experimental: Lutikizumab Dose B Lutikizumab Dose B every other week |
Biological: Lutikizumab
Subcutaneous Injection
Other Names:
|
Experimental: Lutikizumab Dose C Lutikizumab Dose C every other week |
Biological: Lutikizumab
Subcutaneous Injection
Other Names:
|
Placebo Comparator: Placebo Placebo every week |
Drug: Placebo
Subcutaneous Injection
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Inclusion Criteria:
-
A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator.
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A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
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HS lesions must be present in at least 2 distinct anatomic areas.
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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.- M20-262
- 2020-004108-33