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 the signs and symptoms of 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. Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks. Participants in the US that complete Periods 1 & 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen. 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 12 Years
Eligible Sex
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
Experimental
Period 3: Open-label Lutikizumab 		Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981
Experimental
Sub-Study: Lutikizumab Pre-Filled Pen 		Lutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.
  • Drug: Lutikizumab
    Subcutaneous injection
    Other names:
    • ABT-981

Recruiting Locations

Cahaba Dermatology & Skin Health Center /ID# 263795
Birmingham 4049979, Alabama 4829764 35244
Contact:
Site Coordinator
205-778-1564

Medical Dermatology Specialists /ID# 263394
Phoenix 5308655, Arizona 5551752 85006

Banner University Medicine Dermatology /ID# 263557
Tucson 5318313, Arizona 5551752 85718-1407

Dermatology Trial Associates /ID# 264587
Bryant 4103448, Arkansas 4099753 72022

Arkansas Research Trials /ID# 263901
North Little Rock 4124112, Arkansas 4099753 72217

Private Practice - Dr. Tooraj Raoof /ID# 263756
Encino 5346649, California 5332921 91436
Contact:
Site Coordinator
818-714-1431

NorCal Medical Research /ID# 279008
Greenbrae 5354013, California 5332921 94904

Dermatology Research Associates - Los Angeles /ID# 263765
Los Angeles 5368361, California 5332921 90045

Stanford University School of Medicine - Redwood City /ID# 263711
Redwood City 5386834, California 5332921 94063
Contact:
Site Coordinator
(650) 721-7192

Integrative Skin Science and Research /ID# 264600
Sacramento 5389489, California 5332921 95815

Clinical Trials Research Institute /ID# 263743
Thousand Oaks 5402405, California 5332921 91320

Apex Clinical Trials /ID# 263815
Brandon 4148757, Florida 4155751 33511

TrueBlue Clinical Research /ID# 265041
Brandon 4148757, Florida 4155751 33511

Florida Academic Dermatology Center /ID# 263834
Coral Gables 4151871, Florida 4155751 33134-5755

Direct Helpers Research Center /ID# 278343
Hialeah 4158476, Florida 4155751 33012

Skin Care Research - Hollywood /ID# 263805
Hollywood 4158928, Florida 4155751 33021-6748
Contact:
Site Coordinator
9546743535

GSI Clinical Research, LLC /ID# 263827
Margate 4163407, Florida 4155751 33063-7011

Sullivan Dermatology /ID# 263511
Miami 4164138, Florida 4155751 33162

Vitalia Medical Research /ID# 278321
North Palm Beach 4166253, Florida 4155751 33408

Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842
Ocala 4166673, Florida 4155751 34470

Skin Care Research - Tampa /ID# 263819
Tampa 4174757, Florida 4155751 33607-6438

Advanced Clinical Research Institute /ID# 263808
Tampa 4174757, Florida 4155751 33607

University of South Florida /ID# 269624
Tampa 4174757, Florida 4155751 33612

Alliance Clinical Research of Tampa /ID# 264594
Tampa 4174757, Florida 4155751 33615

TruDerm Research /ID# 278217
Wellington 4177703, Florida 4155751 33449

Centricity Research Columbus Dermatology /ID# 266530
Columbus 4188985, Georgia 4197000 31904

Cleaver Medical Group Dermatology /ID# 263845
Dawsonville 4190979, Georgia 4197000 30534

Treasure Valley Medical Research /ID# 263671
Boise 5586437, Idaho 5596512 83706

DeNova Research /ID# 264593
Chicago 4887398, Illinois 4896861 60610

Northwestern University Feinberg School of Medicine /ID# 265007
Chicago 4887398, Illinois 4896861 60611-2927

Arlington Dermatology /ID# 263410
Rolling Meadows 4908052, Illinois 4896861 60008
Contact:
Site Coordinator
847 392 5440

Dawes Fretzin, LLC /ID# 264601
Indianapolis 4259418, Indiana 4921868 46256
Contact:
Site Coordinator
317-516-5030

Dermatology Partners of Leawood /ID# 263533
Leawood 4274317, Kansas 4273857 66211

Equity Medical, LLC /ID# 268590
Bowling Green 4285268, Kentucky 6254925 42104

Dermatology Specialists Research (DS Research) - Kentucky /ID# 263343
Louisville 4299276, Kentucky 6254925 40241
Contact:
Site Coordinator
502-585-9059

Tulane University School of Medicine /ID# 263899
New Orleans 4335045, Louisiana 4331987 70112

Beth Israel Deaconess Medical Center /ID# 263709
Boston 4930956, Massachusetts 6254926 02215

UMass Memorial Medical Center /ID# 274149
Worcester 4956184, Massachusetts 6254926 01605

Hamzavi Dermatology - Canton /ID# 263538
Canton 4987990, Michigan 5001836 48187

Michigan Center for Medical Research /ID# 263547
Clarkston 4988997, Michigan 5001836 48346

Michigan Center for Skin Care Research /ID# 267228
Clinton Township 4989133, Michigan 5001836 48038

Dermatology and Skin Center of Lees Summit /ID# 263567
Lee's Summit 4394870, Missouri 4398678 64064-2301

MediSearch Clinical Trials /ID# 263582
Saint Joseph 4407010, Missouri 4398678 64506
Contact:
Site Coordinator
816-364-1515

Vivida Dermatology- Flamingo /ID# 263716
Las Vegas 5506956, Nevada 5509151 89119-5190

Dartmouth Hitchcock Medical Center - Old Etna Road /ID# 263713
Lebanon 5088597, New Hampshire 5090174 03766

StracSkin, PLLC /ID# 263387
Portsmouth 5091383, New Hampshire 5090174 03801

Mount Sinai Doctors - Dermatology /ID# 264602
New York 5128581, New York 5128638 10028
Contact:
Site Coordinator
212-523-3812

Wake Forest University Baptist Medical Center (WFUBMC) /ID# 264507
Winston-Salem 4499612, North Carolina 4482348 27104

Dermatology of Greater Columbus /ID# 263497
Bexley 4506487, Ohio 5165418 43209

University Hospitals Cleveland Medical Center /ID# 263600
Cleveland 5150529, Ohio 5165418 44106

The Ohio State University Wexner Medical Center - CarePoint East /ID# 263598
Columbus 4509177, Ohio 5165418 43203

Dermatologists of Southwest Ohio - Mason /ID# 263588
Mason 4517698, Ohio 5165418 45040

Apex Clinical Research Center /ID# 272787
Mayfield Heights 5162188, Ohio 5165418 44124

Dermatology Partners /ID# 264999
Philadelphia 4560349, Pennsylvania 6254927 19114

University of Pittsburgh Medical Center /ID# 264590
Pittsburgh 5206379, Pennsylvania 6254927 15213

Clinical Research Center of the Carolinas /ID# 263407
Charleston 4574324, South Carolina 4597040 29407
Contact:
Site Coordinator
843-556-8886 ext 5

Medical University of South Carolina /ID# 263890
Charleston 4574324, South Carolina 4597040 29425

ADCS - Spartanburg /ID# 267207
Spartanburg 4597200, South Carolina 4597040 29307

Arlington Research Center, Inc /ID# 263895
Arlington 4671240, Texas 4736286 76011

Bellaire Dermatology Associates /ID# 263850
Bellaire 4673353, Texas 4736286 77401

Studies in Dermatology LLC /ID# 263399
Cypress 4684724, Texas 4736286 77429

Reveal Research Institute - Dallas /ID# 267233
Dallas 4684888, Texas 4736286 75235

Center for Clinical Studies - Houston - Binz Street /ID# 263378
Houston 4699066, Texas 4736286 77004
Contact:
Site Coordinator
281-343-3300

Texas Dermatology Research Center /ID# 264488
Plano 4719457, Texas 4736286 75025

Texas Dermatology and Laser Specialists /ID# 263778
San Antonio 4726206, Texas 4736286 78218

The Woodlands Dermatology Associates /ID# 266820
The Woodlands 4736476, Texas 4736286 77380

Dermatology Associates of Tyler /ID# 265002
Tyler 4738214, Texas 4736286 75703
Contact:
Site Coordinator
903.534.6200x7209

University of Utah /ID# 263818
Murray 5778755, Utah 5549030 84107

Virginia Clinical Research /ID# 264553
Norfolk 4776222, Virginia 6254928 23507

Frontier Dermatology /ID# 278387
Mill Creek 5803457, Washington 5815135 98012

Dermatology Specialists of Spokane /ID# 264499
Spokane 5811696, Washington 5815135 99202
Contact:
Site Coordinator
509-474-1107

Private Practice - Dr. Alma Cruz /ID# 263204
Carolina 4563243, Puerto Rico 00985

Clinical Research Puerto Rico /ID# 263450
San Juan 4568127, 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