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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
Date last updated
16/07/2025
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
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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
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Secondary ID [1]
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2024-510730-40-00
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Secondary ID [2]
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M20-465
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Universal Trial Number (UTN)
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Trial acronym
Intrepid
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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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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
Experimental: Period 3: Open-label Lutikizumab - Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
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.
Treatment: Drugs: Lutikizumab
Subcutaneous injection
Treatment: Drugs: Placebo
Subcutaneous injection
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Intervention code [1]
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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) 75
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Assessment method [1]
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HiSCR 75 is defined as at least a 75% 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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At 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 62
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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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At Week 8
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Secondary outcome [2]
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Change from Baseline in Dermatology Life Quality Index (DLQI) among participants = 16 years of age at Baseline
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Assessment method [2]
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DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no effect) to 30 (very large effect), with a higher score indicating a more impaired quality of life.
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Timepoint [2]
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At Week 16
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Secondary outcome [3]
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Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
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Assessment method [3]
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The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.
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Timepoint [3]
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At Week 16
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Secondary outcome [4]
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Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score
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Assessment method [4]
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The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (HS) in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
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Timepoint [4]
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At Week 16
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Secondary outcome [5]
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Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline
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Assessment method [5]
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Timepoint [5]
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At Week 16
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Secondary outcome [6]
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Percentage of Participants Achieving HiSCR 90
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Assessment method [6]
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HiSCR 90 is defined as at least a 90% 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 [6]
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At Week 16
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Secondary outcome [7]
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Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS)
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Assessment method [7]
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Timepoint [7]
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At Week 8
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Secondary outcome [8]
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Change from Baseline in HSSA
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Assessment method [8]
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The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (HS) in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
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Timepoint [8]
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At Week 16
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Secondary outcome [9]
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Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8
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Assessment method [9]
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The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
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Timepoint [9]
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At Week 16
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Secondary outcome [10]
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Percentage of Participants with an Occurrence of HS Flare in Period 1
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Assessment method [10]
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HS Flare is defined as at least one occurrence of a = 25% increase in AN count with a minimum absolute increase of 2 relative to Baseline.
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Timepoint [10]
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Baseline to Week 16
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Secondary outcome [11]
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Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain
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Assessment method [11]
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Timepoint [11]
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At Week 16
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Secondary outcome [12]
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Change from Baseline in HSIA Mobility Domain
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Assessment method [12]
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Timepoint [12]
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at Week 16
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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.
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Minimum age
12
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
* 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
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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 administering 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 3
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Type of endpoint/s
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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
27/06/2024
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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
1/12/2026
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Actual
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Sample size
Target
1280
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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,VIC
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Recruitment hospital [1]
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Paratus Clinical Research Woden /ID# 263125 - Phillip
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Recruitment hospital [2]
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Momentum Clinical Research /ID# 263192 - Darlinghurst
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Recruitment hospital [3]
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Premier Dermatology /ID# 263124 - Kogarah
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Veracity Clinical Research /ID# 263126 - Woolloongabba
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Recruitment hospital [5]
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Sinclair Dermatology - Melbourne /ID# 263121 - East Melbourne
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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 postcode(s) [5]
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3002 - East Melbourne
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Recruitment outside Australia
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Bristol
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Funding & Sponsors
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Commercial sector/industry
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Name
AbbVie
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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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT06468228
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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ABBVIE CALL CENTER
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844-663-3742
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/study/NCT06468228
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