A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Purpose

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. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 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

  • Hidradenitis Suppurativa

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant). - Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline - Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline. - At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.

Exclusion Criteria

  • Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Confirmed positive anti-HIV antibody (HIV Ab) test. - Evidence of active tuberculosis or meets tuberculosis exclusionary parameter

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Period 1 		Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981
  • Drug: Placebo
    Subcutaneous injection
Experimental
Period 2: Lutikizumab Every Week 		Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981
Experimental
Period 2: Lutikizumab Every Other Week 		Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981
  • Drug: Placebo
    Subcutaneous injection
Experimental
Period 2: Placebo to Lutikizumab Group 		Participants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week.
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981
Experimental
Period 2: Placebo to Lutikizumab Group Every Week 		Participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981
Experimental
Period 2: Placebo to Lutikizumab Group Every Other Week 		The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981
  • Drug: Placebo
    Subcutaneous injection

Recruiting Locations

Cahaba Dermatology & Skin Health Center /ID# 263795
Birmingham, Alabama 35244
Contact:
Site Coordinator
205-778-1564

Medical Dermatology Specialists /ID# 263394
Phoenix, Arizona 85006

Dermatology Trial Associates /ID# 264587
Bryant, Arkansas 72022

Arkansas Research Trials /ID# 263901
North Little Rock, Arkansas 72217

Joseph Raoof Md,Inc /Id# 263756
Encino, California 91436
Contact:
Site Coordinator
818-714-1431

Dermatology Research Associates - Los Angeles /ID# 263765
Los Angeles, California 90045

Stanford University School of Medicine - Redwood City /ID# 263711
Redwood City, California 94063-3132
Contact:
Site Coordinator
(650) 721-7192

Integrative Skin Science and Research /ID# 264600
Sacramento, California 95815

Clinical Trials Research Institute /ID# 263743
Thousand Oaks, California 91320

Clearlyderm Dermatology - West Boca /ID# 265023
Boca Raton, Florida 33428

Apex Clinical Trials /ID# 263815
Brandon, Florida 33511

TrueBlue Clinical Research /ID# 265041
Brandon, Florida 33511

Skin Care Research - Hollywood /ID# 263805
Hollywood, Florida 33021-6748
Contact:
Site Coordinator
9546743535

GSI Clinical Research, LLC /ID# 263827
Margate, Florida 33063-7011

Sullivan Dermatology /ID# 263511
Miami, Florida 33162

Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842
Ocala, Florida 34470

Skin Care Research - Tampa /ID# 263819
Tampa, Florida 33607-6438

Advanced Clinical Research Institute /ID# 263808
Tampa, Florida 33607

Alliance Clinical Research of Tampa /ID# 264594
Tampa, Florida 33615

Centricity Research Columbus Dermatology /ID# 266530
Columbus, Georgia 31904

Cleaver Medical Group Dermatology /ID# 263845
Dawsonville, Georgia 30534

Treasure Valley Medical Research /ID# 263671
Boise, Idaho 83706

Northwestern University Feinberg School of Medicine /ID# 265007
Chicago, Illinois 60611-2927

Arlington Dermatology /ID# 263410
Rolling Meadows, Illinois 60008
Contact:
Site Coordinator
847 392 5440

Dawes Fretzin, LLC /ID# 264601
Indianapolis, Indiana 46256
Contact:
Site Coordinator
317-516-5030

Dermatology Partners of Leawood /ID# 263533
Leawood, Kansas 66211

Equity Medical, LLC /ID# 268590
Bowling Green, Kentucky 42104

Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343
Louisville, Kentucky 40241
Contact:
Site Coordinator
502-585-9059

Hamzavi Dermatology - Canton /ID# 263538
Canton, Michigan 48187

Michigan Center for Medical Research /ID# 263547
Clarkston, Michigan 48346

Dermatology and Skin Center of Lees Summit /ID# 263567
Lee's Summit, Missouri 64064-2301

MediSearch Clinical Trials /ID# 263582
Saint Joseph, Missouri 64506
Contact:
Site Coordinator
816-364-1515

Vivida Dermatology- Flamingo /ID# 263716
Las Vegas, Nevada 89119-5190

Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713
Lebanon, New Hampshire 03766

ActivMed Practice and Research, LLC /ID# 263387
Portsmouth, New Hampshire 03801

Mount Sinai Doctors - Dermatology /ID# 264602
New York, New York 10028
Contact:
Site Coordinator
212-523-3812

Atrium Health Wake Forest Baptist Medical Center /ID# 264507
Winston-Salem, North Carolina 27157

Dermatology of Greater Columbus /ID# 263497
Bexley, Ohio 43209

University Hospitals Cleveland Medical Center /ID# 263600
Cleveland, Ohio 44106

Ohio State Officenter Gahanna /ID# 263598
Gahanna, Ohio 43230

Dermatologists of Southwest Ohio - Mason /ID# 263588
Mason, Ohio 45040

Apex Clinical Research Center /ID# 272787
Mayfield Heights, Ohio 44124

Dermatology Partners /ID# 264999
Philadelphia, Pennsylvania 19114

University of Pittsburgh Medical Center /ID# 264590
Pittsburgh, Pennsylvania 15213

Clinical Research Center of the Carolinas /ID# 263407
Charleston, South Carolina 29407
Contact:
Site Coordinator
843-556-8886 ext 5

Medical University of South Carolina /ID# 263890
Charleston, South Carolina 29425

ADCS - Spartanburg /ID# 267207
Spartanburg, South Carolina 29307

Arlington Research Center, Inc /ID# 263895
Arlington, Texas 76011

Bellaire Dermatology Associates /ID# 263850
Bellaire, Texas 77401

Studies in Dermatology LLC /ID# 263399
Cypress, Texas 77429

Reveal Research Institute, Dallas /ID# 267233
Dallas, Texas 75235-2519

Center for Clinical Studies - Houston - Binz Street /ID# 263378
Houston, Texas 77004
Contact:
Site Coordinator
281-343-3300

Texas Dermatology Research Center /ID# 264488
Plano, Texas 75025

Texas Dermatology and Laser Specialists /ID# 263778
San Antonio, Texas 78218

Dermatology Associates of Tyler /ID# 265002
Tyler, Texas 75703
Contact:
Site Coordinator
903.534.6200x7209

University of Utah /ID# 263818
Murray, Utah 84107

Virginia Clinical Research /ID# 264553
Norfolk, Virginia 23507

Dermatology Specialists of Spokane /ID# 264499
Spokane, Washington 99202
Contact:
Site Coordinator
509-474-1107

Private Practice - Dr. Alma Cruz /ID# 263204
Carolina, Puerto Rico 00985

Clinical Research Puerto Rico /ID# 263450
San Juan, Puerto Rico 00909-1711
Contact:
Site Coordinator
787-723-5945

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com