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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06468228




Registration number
NCT06468228
Ethics application status
Date submitted
17/06/2024
Date registered
21/06/2024

Titles & IDs
Public title
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Scientific title
A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa
Secondary ID [1] 0 0
2024-510730-40-00
Secondary ID [2] 0 0
M20-465
Universal Trial Number (UTN)
Trial acronym
Intrepid
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: Drugs - Lutikizumab
Treatment: Drugs - Placebo

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 .

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

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

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.

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

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


Treatment: Drugs: Lutikizumab
Subcutaneous injection

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Timepoint [1] 0 0
At Week 16
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to Approximately Week 62
Secondary outcome [1] 0 0
Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
Timepoint [1] 0 0
At Week 8
Secondary outcome [2] 0 0
Change from Baseline in Dermatology Life Quality Index (DLQI)
Timepoint [2] 0 0
At Week 16
Secondary outcome [3] 0 0
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
Timepoint [3] 0 0
At Week 16
Secondary outcome [4] 0 0
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score
Timepoint [4] 0 0
At Week 16
Secondary outcome [5] 0 0
Change from Baseline in Draining Fistula Count
Timepoint [5] 0 0
At Week 16
Secondary outcome [6] 0 0
Percentage of Participants Achieving HiSCR 90
Timepoint [6] 0 0
At Week 16
Secondary outcome [7] 0 0
Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS)
Timepoint [7] 0 0
At Week 8
Secondary outcome [8] 0 0
Change from Baseline in HSSA
Timepoint [8] 0 0
At Week 16
Secondary outcome [9] 0 0
Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8
Timepoint [9] 0 0
At Week 16
Secondary outcome [10] 0 0
Percentage of Participants with an Occurrence of HS Flare in Period 1
Timepoint [10] 0 0
Baseline to Week 16

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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 administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
27/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
1280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden /ID# 263125 - Phillip
Recruitment hospital [2] 0 0
Momentum Clinical Research /ID# 263192 - Darlinghurst
Recruitment hospital [3] 0 0
Premier Dermatology /ID# 263124 - Kogarah
Recruitment hospital [4] 0 0
Veracity Clinical Research /ID# 263126 - Woolloongabba
Recruitment hospital [5] 0 0
Sinclair Dermatology - Melbourne /ID# 263121 - East Melbourne
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 postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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Arizona
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Arkansas
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California
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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Michigan
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Missouri
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Nevada
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New Hampshire
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Washington
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Israel
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H_efa
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Israel
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HaMerkaz
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Israel
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HaTsafon
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Israel
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Tel-Aviv
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Israel
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Jerusalem
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Japan
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Aichi
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Japan
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Hokkaido
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Japan
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Kyoto
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Japan
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Okinawa
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Osaka
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Saitama
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Fukuoka
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Tokyo
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Waikato
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Auckland
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Puerto Rico
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Carolina
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San Juan
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Sweden
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Örebro
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Switzerland
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Nidwalden
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Switzerland
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Sankt Gallen
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Taiwan
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Kaohsiung
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Taipei
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Taiwan
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Taipei City
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Taiwan
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Taoyuan City

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
abbvieclinicaltrials@abbvie.com
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/NCT06468228