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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
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
Secondary ID [1] 0 0
U1111-1280-6493
Secondary ID [2] 0 0
ACT16852
Universal Trial Number (UTN)
Trial acronym
HS OBTAIN
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Time to onset of achieving HiSCR50
Timepoint [1] 0 0
Up to week 16
Secondary outcome [2] 0 0
Percentage of participants achieving HiSCR75 at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of participants achieving HiSCR90 at week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Change in absolute score from Baseline in IHS4 at week 16
Timepoint [5] 0 0
From Baseline to week 16
Secondary outcome [6] 0 0
Percentage of participants who experience a flare
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Percentage of participants achieving IHS4-55
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions
Timepoint [8] 0 0
Up to week 36
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Serum SAR442970 concentrations throughout the study
Timepoint [10] 0 0
Up to 36 weeks
Secondary outcome [11] 0 0
Incidence of anti-SAR442970 antibody positive response throughout the study
Timepoint [11] 0 0
Up to 36 weeks

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

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 assessing the outcomes
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/01/2025
Actual
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360002 - Liverpool
Recruitment hospital [2] 0 0
Investigational Site Number : 0360005 - Westmead
Recruitment hospital [3] 0 0
Investigational Site Number : 0360003 - Woolloongabba
Recruitment hospital [4] 0 0
Investigational Site Number : 0360001 - Carlton
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Rhode Island
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Sint-Lambrechts-Woluwe
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Chile
State/province [10] 0 0
Reg Metropolitana De Santiago
Country [11] 0 0
Czechia
State/province [11] 0 0
Ostrava - Poruba
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha 10
Country [13] 0 0
Czechia
State/province [13] 0 0
Praha 5 - Motol
Country [14] 0 0
Denmark
State/province [14] 0 0
Roskilde
Country [15] 0 0
France
State/province [15] 0 0
Lyon
Country [16] 0 0
France
State/province [16] 0 0
Nice
Country [17] 0 0
France
State/province [17] 0 0
Reims
Country [18] 0 0
France
State/province [18] 0 0
Saint Mande
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Bochum
Country [21] 0 0
Germany
State/province [21] 0 0
Frankfurt am Main
Country [22] 0 0
Germany
State/province [22] 0 0
Mainz
Country [23] 0 0
Germany
State/province [23] 0 0
Münster
Country [24] 0 0
Greece
State/province [24] 0 0
Athens
Country [25] 0 0
Italy
State/province [25] 0 0
Lombardia
Country [26] 0 0
Italy
State/province [26] 0 0
Catania
Country [27] 0 0
Netherlands
State/province [27] 0 0
Breda
Country [28] 0 0
Netherlands
State/province [28] 0 0
Groningen
Country [29] 0 0
Netherlands
State/province [29] 0 0
Rotterdam
Country [30] 0 0
Poland
State/province [30] 0 0
Mazowieckie
Country [31] 0 0
Poland
State/province [31] 0 0
Lodz
Country [32] 0 0
Poland
State/province [32] 0 0
Wroclaw
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona [Barcelona]
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid, Comunidad De
Country [35] 0 0
Spain
State/province [35] 0 0
Valencia
Country [36] 0 0
Spain
State/province [36] 0 0
Córdoba
Country [37] 0 0
Sweden
State/province [37] 0 0
Alvsjo

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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