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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05139602
Registration number
NCT05139602
Ethics application status
Date submitted
29/11/2021
Date registered
1/12/2021
Date last updated
16/04/2024
Titles & IDs
Public 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 and Who Are Naïve to Biologic Therapy
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Scientific 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: Amended Protocol to Include a Lutikizumab Open-Label Sub-study in Subjects Naïve to Biologic Therapy
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Secondary ID [1]
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2020-004108-33
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Secondary ID [2]
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M20-262
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Lutikizumab
Treatment: Drugs - Placebo
Experimental: Main Study: Lutikizumab Dose A - Lutikizumab Dose A every week
Experimental: Main Study: Lutikizumab Dose B - Lutikizumab Dose B every other week
Experimental: Main Study: Lutikizumab Dose C - Lutikizumab Dose C every other week
Placebo Comparator: Main Study: Placebo - Placebo every week
Experimental: Sub-study: Group 1 - Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.
Experimental: Sub-study: Group 2 - Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.
Other interventions: Lutikizumab
Subcutaneous Injection
Treatment: Drugs: Placebo
Subcutaneous Injection
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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Timepoint [2]
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Up to Approximately Week 68
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Secondary outcome [1]
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Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16
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Eligibility
Key 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.
- To be eligible for the Sub-study, participants must be naïve to biologic therapy for
treatment of HS.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/01/2026
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
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Recruitment hospital [1]
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Duplicate_Paratus Clinical Research Woden /ID# 240605 - Phillip
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Recruitment hospital [2]
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Holdsworth House Medical Practice /ID# 240911 - Darlinghurst
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Recruitment hospital [3]
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Premier Specialist /ID# 241288 - Kogarah
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Recruitment hospital [4]
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Veracity Clinical Research /ID# 241096 - Woolloongabba
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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Arizona
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
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. In
the Main Study, 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. In the Sub-study, participants will be put in 1 of 2
groups, called treatment arms. Both arms will receive treatment at different dosing
intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic
therapy will be enrolled in the study at certain sites.
In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981)
or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous
injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week
or every other week for 36 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05139602
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Phone
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844-663-3742
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05139602
Download to PDF