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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05139602




Registration number
NCT05139602
Ethics application status
Date submitted
29/11/2021
Date registered
1/12/2021

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
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
Secondary ID [1] 0 0
2020-004108-33
Secondary ID [2] 0 0
M20-262
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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.


Treatment: Other: Lutikizumab
Subcutaneous Injection

Treatment: Drugs: Placebo
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to Approximately Week 68
Secondary outcome [1] 0 0
Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
Timepoint [1] 0 0
Week 16

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/01/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
Duplicate_Paratus Clinical Research Woden /ID# 240605 - Phillip
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice /ID# 240911 - Darlinghurst
Recruitment hospital [3] 0 0
Premier Specialist /ID# 241288 - Kogarah
Recruitment hospital [4] 0 0
Veracity Clinical Research /ID# 241096 - Woolloongabba
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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Nebraska
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New Jersey
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New York
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Oklahoma
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United States of America
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Texas
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Canada
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Alberta
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Canada
State/province [16] 0 0
Manitoba
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Canada
State/province [17] 0 0
Ontario
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Canada
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Quebec
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Germany
State/province [19] 0 0
Bayern
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dessau
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Germany
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Hamburg
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Greece
State/province [24] 0 0
Attiki
Country [25] 0 0
Greece
State/province [25] 0 0
Thessaloniki
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Kyoto
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Japan
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Okinawa
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Japan
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Osaka
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Puerto Rico
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Carolina
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Spain
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Valencia
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Spain
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Barcelona
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Spain
State/province [34] 0 0
Granada
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05139602