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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06118099
Registration number
NCT06118099
Ethics application status
Date submitted
31/10/2023
Date registered
7/11/2023
Titles & IDs
Public title
Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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Secondary ID [1]
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U1111-1290-9497
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Secondary ID [2]
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ACT17967
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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
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Placebo
Experimental: Amlitelimab - Subcutaneous injection (SC) as per protocol.
Placebo comparator: Placebo - Subcutaneous injection as per protocol.
Treatment: Drugs: Amlitelimab
Injection solution SC injection
Treatment: Drugs: Placebo
Injection solution SC 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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The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
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Assessment method [1]
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Hidradenitis suppurativa clinical response (HiSCR)50 is defined as =50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Time to onset of achieving HiSCR50
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Assessment method [1]
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HiSCR50 is defined as =50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
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Timepoint [1]
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From baseline to Week 16
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Secondary outcome [2]
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Absolute change from baseline in AN count at Week 16
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Assessment method [2]
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AN count is the total abscess and inflammatory nodule count.
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Timepoint [2]
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Baseline to Week 16
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Secondary outcome [3]
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Percentage change in AN count at Week 16
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Assessment method [3]
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AN count is the total abscess and inflammatory nodule count.
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Timepoint [3]
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Baseline to Week 16
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Secondary outcome [4]
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Percentage of participants achieving HiSCR75 at Week 16
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Assessment method [4]
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HiSCR75 is defined as =75% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of participants achieving HiSCR90 at Week 16
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Assessment method [5]
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HiSCR90 is defined as =90% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16
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Assessment method [6]
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The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Change in absolute score from Baseline in IHS4 at Week 16
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Assessment method [7]
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The IHS4 is a validated tool to assess HS severity. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
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Timepoint [7]
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Baseline to Week 16
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Secondary outcome [8]
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Percentage of participants who experience a flare at Week 16
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Assessment method [8]
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A flare is defined as at least a 25% increase in AN count (with a minimum increase of 2 AN) relative to baseline. AN count is the total abscess and inflammatory nodule count.
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Timepoint [8]
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Week 16
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Secondary outcome [9]
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Percentage of participants achieving IHS4-55 at Week 16
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Assessment method [9]
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IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from baseline. A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily HS-Skin Pain NRS at Week 16 among participants with baseline NRS =3
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Assessment method [10]
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Hidradenitis Suppurativa-Skin pain-numeric rating scale (HS-Skin pain NRS) is scored on a 0 to 10 scale with 0 indicating "no skin pain" and 10 indicating "worst skin pain possible".
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Timepoint [10]
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Week 16
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Secondary outcome [11]
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Percentage of participants with improvement (reduction) in Peak Pruritus Numerical Rating Scale (PP-NRS) =4 from Baseline at Week 16 among participants with baseline PP-NRS =4
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Assessment method [11]
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PP-NRS is a validated single item 0 (no itch) to10 (worst itch imaginable) numeric rating scale assessing peak pruritus (itch).
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Timepoint [11]
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Week 16
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Secondary outcome [12]
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Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI =4
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Assessment method [12]
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Dermatology life quality index (DLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL). Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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Timepoint [12]
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Week 16
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Secondary outcome [13]
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Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16
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Assessment method [13]
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HiSQOL is an instrument designed to measure the HS-specific health-related QoL of adults with HS.
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Timepoint [13]
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Baseline to Week 16
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Secondary outcome [14]
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Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interest (AESIs), and serious adverse events (SAEs) including local injection site reactions in the Safety Population
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Assessment method [14]
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Timepoint [14]
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Baseline up to Week 116
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Secondary outcome [15]
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Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population
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Assessment method [15]
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Timepoint [15]
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Baseline up to Week 116
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Secondary outcome [16]
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Serum amlitelimab concentrations measured at prespecified time points in the PK population
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Assessment method [16]
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Timepoint [16]
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Day 1 up to Week 116
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Secondary outcome [17]
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Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population
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Assessment method [17]
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Timepoint [17]
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Day 1 up to Week 116
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Eligibility
Key inclusion criteria
* Participant must be 18 (or country's age of majority if >18) years to 70 years of age inclusive, at the time of signing the informed consent.
* Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
* Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
* Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS
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Minimum age
18
Years
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Maximum age
70
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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
* Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc)
* Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
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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 assessing the outcomes
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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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
1/11/2023
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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
14/01/2027
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Actual
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Sample size
Target
84
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360003 - Phillip
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Recruitment hospital [2]
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Investigational Site Number : 0360001 - Darlinghurst
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Recruitment hospital [3]
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Investigational Site Number : 0360002 - 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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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Missouri
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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Rhode Island
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Canada
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State/province [9]
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Quebec
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Country [10]
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Chile
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State/province [10]
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Reg Metropolitana De Santiago
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Country [11]
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France
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State/province [11]
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La Rochelle
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Country [12]
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France
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State/province [12]
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Lyon
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Country [13]
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France
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State/province [13]
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Reims
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Country [14]
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France
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State/province [14]
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Rouen
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Country [15]
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France
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State/province [15]
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Saint Mande
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Germany
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State/province [16]
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Bochum
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Germany
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State/province [17]
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Münster
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Hungary
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State/province [18]
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Italy
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State/province [21]
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Catania
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Italy
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State/province [22]
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Cona (Ferrara)
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Poland
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State/province [23]
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Mazowieckie
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Lisboa
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Spain
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Barcelona [Barcelona]
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Spain
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Catalunya [Cataluña]
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Country [29]
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Spain
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State/province [29]
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Las Palmas
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Country [30]
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Spain
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State/province [30]
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Madrid, Comunidad De
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment. Study details include: * The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period. * All participants who complete the 16-week DBT period will be offered entry into an optional LTE. * Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period. * The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.
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Trial website
https://clinicaltrials.gov/study/NCT06118099
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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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Clinical Sciences & Operations
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Address
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Sanofi
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT06118099