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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05849922
Registration number
NCT05849922
Ethics application status
Date submitted
28/04/2023
Date registered
9/05/2023
Titles & IDs
Public title
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa
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Secondary ID [1]
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U1111-1280-6493
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Secondary ID [2]
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ACT16852
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Universal Trial Number (UTN)
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Trial acronym
HS OBTAIN
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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
Treatment: Drugs - SAR442970
Treatment: Drugs - Placebo
Experimental: SAR442970 - Participants will receive SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).
Placebo comparator: Placebo - Participants will receive placebo Q2W in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).
Treatment: Drugs: SAR442970
1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial
Treatment: Drugs: Placebo
1 mL extractable volume of placebo filled in 2 mL glass vial
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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 biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)
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Assessment method [1]
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HiSCR50 is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] 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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Timepoint [1]
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Up to week 16
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Secondary outcome [2]
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Percentage of participants achieving HiSCR75 at Week 16
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Assessment method [2]
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HiSCR75 is defined as at least a 75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of participants achieving HiSCR90 at week 16
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Assessment method [3]
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HiSCR90 is defined as at least a 90% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16
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Assessment method [4]
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The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Change in absolute score from Baseline in IHS4 at week 16
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Assessment method [5]
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Timepoint [5]
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From Baseline to week 16
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Secondary outcome [6]
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Percentage of participants who experience a flare
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Assessment method [6]
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Flare is defined as at least 25% increase in the total abscess and inflammatory nodule \[AN\] count (with a minimum increase of 2) relative to Baseline at week 16.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Percentage of participants achieving IHS4-55
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Assessment method [7]
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IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from Baseline
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions
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Assessment method [8]
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Timepoint [8]
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Up to week 36
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Secondary outcome [9]
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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 Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-SkinPainNRS) at Week 16 among participants with Baseline NRS =3
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Assessment method [9]
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Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period)
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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Serum SAR442970 concentrations throughout the study
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Assessment method [10]
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Timepoint [10]
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Up to 36 weeks
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Secondary outcome [11]
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Incidence of anti-SAR442970 antibody positive response throughout the study
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Assessment method [11]
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Timepoint [11]
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Up to 36 weeks
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Eligibility
Key inclusion criteria
* Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (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 inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
* Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
* Participants must be either biologic and small molecule immunosuppressive-naïve or TNF-experienced.
* Participant must have a total abscess and inflammatory nodule (AN) count of =3 at the Baseline visit.
* Participant must have a draining tunnel count of =20 at the Baseline visit.
* Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit.
* Participant who is a candidate for systemic treatment per Investigator's judgment.
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Minimum age
18
Years
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Maximum age
70
Years
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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 other active skin disease or condition (eg, bacterial, fungal or viral infection) that may interfere with assessment of HS
* History of recurrent or recent serious infection
* Known history of or suspected significant current immunosuppression
* History of solid organ transplant
* History of splenectomy
* History of moderate to severe congestive heart failure
* Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
* History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
* Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
* Participants with a diagnosis of inflammatory conditions other than HS
* Presence of active suicidal ideation, or positive suicide behavior or participant has a lifetime history of suicide attempt, or participant has had suicidal ideation in the past 6 months as indicated by a positive response using the screening or Baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history
* A history of an adverse event (AE) to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
* Female participants who are breastfeeding or considering becoming pregnant during the study
* History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
* Laboratory exclusion criteria apply
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
Active, not 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
6/06/2023
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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
8/01/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360002 - Liverpool
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Recruitment hospital [2]
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Investigational Site Number : 0360005 - Westmead
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Recruitment hospital [3]
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Investigational Site Number : 0360003 - Woolloongabba
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Recruitment hospital [4]
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Investigational Site Number : 0360001 - Carlton
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3053 - Carlton
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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Florida
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Belgium
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Leuven
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Belgium
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Sint-Lambrechts-Woluwe
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Ontario
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Praha 5 - Motol
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Roskilde
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Lyon
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France
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Nice
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France
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Reims
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France
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Saint Mande
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Germany
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Berlin
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Germany
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Germany
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Mainz
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Germany
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Münster
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Athens
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Catania
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Lodz
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Barcelona [Barcelona]
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Spain
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Madrid, Comunidad De
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Spain
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Valencia
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Córdoba
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Sweden
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Alvsjo
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.
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Trial website
https://clinicaltrials.gov/study/NCT05849922
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Address
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Sanofi
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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/NCT05849922