Back to resultsA 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
Primary Purpose
Hidradenitis Suppurativa
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lutikizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Lutikizumab, ABT-981
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.
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.
Sites / Locations
- Medical Dermatology Specialist /ID# 240641
- Mayo Clinic - Scottsdale /ID# 241030
- Burke Pharmaceutical Research /ID# 240811
- UCSF Fresno /ID# 240903
- Medderm Associates /ID# 240729
- Clinical Trials Research Institute /ID# 240642
- CCD Research, PLLC /ID# 240728
- Skin Care Research - Boca Raton /ID# 240758
- Apex Clinical Trials /ID# 248558
- GSI Clinical Research, LLC /ID# 240901
- Florida International Rsrch cr /ID# 240902
- Park Avenue Dermatology, PA /ID# 240807
- TruDerm Dermatology of Wellington /ID# 240780
- Dawes Fretzin, LLC /ID# 240701
- Beth Israel Deaconess Medical Center /ID# 240683
- Revival Research Institute, LLC /ID# 241020
- MediSearch Clinical Trials /ID# 240810
- Washington University-School of Medicine /ID# 240797
- Advanced Dermatology of the Midlands /ID# 249750
- Skin Specialists, PC /ID# 240804
- Psoriasis Treatment Center of Central New Jersey /ID# 240900
- Montefiore Medical Center /ID# 240853
- Mount Sinai Doctors Dermatology /ID# 241588
- Essential Medical Research, LLC /ID# 241807
- Center for Clinical Studies - Houston (Binz) /ID# 240692
- Paratus Clinical Research Woden /ID# 240605
- Holdsworth House Medical Practice /ID# 240911
- Premier Specialist /ID# 241288
- Veracity Clinical Research /ID# 241096
- Beacon Dermatology Inc /ID# 240741
- Wiseman Dermatology Research /ID# 240738
- Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814
- Dr. S.K. Siddha Medicine Professional Corporation /ID# 247986
- Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
- Universitaetsklinikum Erlangen /ID# 240872
- Havelklinik /ID# 240874
- Klinikum Ruhr Univ Bochum /ID# 240870
- Staedtisches Klinikum Dessau /ID# 240871
- Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 240873
- 401 GSNA - 401 Army General Hospital /ID# 242189
- University General Hospital Attikon /ID# 240371
- General Hospital Andreas Syggros /ID# 241104
- Papageorgiou General Hospital Thessaloniki /ID# 240385
- General Hospital of Thessaloniki Hippokrateio /ID# 240697
- Nagoya City University Hospital /ID# 244392
- Fukuoka University Hospital /ID# 244390
- University Hospital Kyoto Prefectural University of Medicine /ID# 244739
- University of the Ryukyus Hospital /ID# 244848
- Kindai University Hospital /ID# 245358
- Dr. Alma Cruz Santana Private practice /ID# 244514
- Hospital de Manises /ID# 240440
- Hospital Santa Creu i Sant Pau /ID# 240529
- Hospital Universitario Virgen de las Nieves /ID# 240429
- Hospital General Universitario Gregorio Maranon /ID# 240396
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Lutikizumab Dose A
Lutikizumab Dose B
Lutikizumab Dose C
Placebo
Arm Description
Lutikizumab Dose A every week
Lutikizumab Dose B every other week
Lutikizumab Dose C every other week
Placebo every week
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05139602
Brief Title
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
Official Title
A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab (ABT-981) in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
August 25, 2023 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis Suppurativa, Lutikizumab, ABT-981
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lutikizumab Dose A
Arm Type
Experimental
Arm Description
Lutikizumab Dose A every week
Arm Title
Lutikizumab Dose B
Arm Type
Experimental
Arm Description
Lutikizumab Dose B every other week
Arm Title
Lutikizumab Dose C
Arm Type
Experimental
Arm Description
Lutikizumab Dose C every other week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo every week
Intervention Type
Biological
Intervention Name(s)
Lutikizumab
Other Intervention Name(s)
ABT-981
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
Description
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.
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Medical Dermatology Specialist /ID# 240641
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2722
Country
United States
Facility Name
Mayo Clinic - Scottsdale /ID# 241030
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5452
Country
United States
Facility Name
Burke Pharmaceutical Research /ID# 240811
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913-6404
Country
United States
Facility Name
UCSF Fresno /ID# 240903
City
Fresno
State/Province
California
ZIP/Postal Code
93701-2302
Country
United States
Facility Name
Medderm Associates /ID# 240729
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Trials Research Institute /ID# 240642
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320-2130
Country
United States
Facility Name
CCD Research, PLLC /ID# 240728
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416-1745
Country
United States
Facility Name
Skin Care Research - Boca Raton /ID# 240758
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486-2269
Country
United States
Facility Name
Apex Clinical Trials /ID# 248558
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
GSI Clinical Research, LLC /ID# 240901
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Florida International Rsrch cr /ID# 240902
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Park Avenue Dermatology, PA /ID# 240807
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
TruDerm Dermatology of Wellington /ID# 240780
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Dawes Fretzin, LLC /ID# 240701
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 240683
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Revival Research Institute, LLC /ID# 241020
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084-3536
Country
United States
Facility Name
MediSearch Clinical Trials /ID# 240810
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Washington University-School of Medicine /ID# 240797
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Advanced Dermatology of the Midlands /ID# 249750
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144-1105
Country
United States
Facility Name
Skin Specialists, PC /ID# 240804
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey /ID# 240900
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Montefiore Medical Center /ID# 240853
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Doctors Dermatology /ID# 241588
City
New York
State/Province
New York
ZIP/Postal Code
10029-6504
Country
United States
Facility Name
Essential Medical Research, LLC /ID# 241807
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137-2842
Country
United States
Facility Name
Center for Clinical Studies - Houston (Binz) /ID# 240692
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-8097
Country
United States
Facility Name
Paratus Clinical Research Woden /ID# 240605
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Holdsworth House Medical Practice /ID# 240911
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Premier Specialist /ID# 241288
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Veracity Clinical Research /ID# 241096
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Beacon Dermatology Inc /ID# 240741
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
Wiseman Dermatology Research /ID# 240738
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L3C3
Country
Canada
Facility Name
Dr. S.K. Siddha Medicine Professional Corporation /ID# 247986
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Universitaetsklinikum Erlangen /ID# 240872
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Havelklinik /ID# 240874
City
Berlin
ZIP/Postal Code
13595
Country
Germany
Facility Name
Klinikum Ruhr Univ Bochum /ID# 240870
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Staedtisches Klinikum Dessau /ID# 240871
City
Dessau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 240873
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
401 GSNA - 401 Army General Hospital /ID# 242189
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital Attikon /ID# 240371
City
Athens
State/Province
Attiki
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital Andreas Syggros /ID# 241104
City
Athens
State/Province
Attiki
ZIP/Postal Code
16121
Country
Greece
Facility Name
Papageorgiou General Hospital Thessaloniki /ID# 240385
City
Stavroupoli (Thessalonikis)
State/Province
Thessaloniki
ZIP/Postal Code
55536
Country
Greece
Facility Name
General Hospital of Thessaloniki Hippokrateio /ID# 240697
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Nagoya City University Hospital /ID# 244392
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Fukuoka University Hospital /ID# 244390
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine /ID# 244739
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
University of the Ryukyus Hospital /ID# 244848
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Kindai University Hospital /ID# 245358
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Dr. Alma Cruz Santana Private practice /ID# 244514
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Facility Name
Hospital de Manises /ID# 240440
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 240529
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves /ID# 240429
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 240396
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this 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
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