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A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (HS OBTAIN)

Primary Purpose

Hidradenitis Suppurativa

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR442970
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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.

Sites / Locations

  • ForCare Clinical Research_Investigational Site Number: 8400006Recruiting
  • Center for Clinical Studies, LTD.LLP_Investigational Site Number: 8400003Recruiting
  • Investigational Site Number: 0360002Recruiting
  • Investigational Site Number: 0360005Recruiting
  • Investigational Site Number :0360003Recruiting
  • Investigational Site Number :0360001Recruiting
  • Investigational Site Number :1240001Recruiting
  • Investigational Site Number :1240002Recruiting
  • Investigational Site Number :1240004Recruiting
  • Investigational Site Number: 1240007Recruiting
  • Investigational Site Number :1520003Recruiting
  • Investigational Site Number :1520001Recruiting
  • Investigational Site Number :1520002Recruiting
  • Investigational Site Number: 3800001Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR442970

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)
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

Secondary Outcome Measures

Time to onset of achieving HiSCR50
Percentage of participants achieving HiSCR75 at Week 16
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
Percentage of participants achieving HiSCR90 at week 16
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
Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient
Change in absolute score from Baseline in IHS4 at week 16
Percentage of participants who experience a flare
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.
Percentage of participants achieving IHS4-55
IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from Baseline
Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions
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
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)
Serum SAR442970 concentrations throughout the study
Incidence of anti-SAR442970 antibody positive response throughout the study

Full Information

First Posted
April 28, 2023
Last Updated
October 10, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05849922
Brief Title
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Acronym
HS OBTAIN
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
October 17, 2024 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study duration will be up to 40 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAR442970
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
SAR442970
Intervention Description
1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 mL extractable volume of placebo filled in 2 mL glass vial
Primary Outcome Measure Information:
Title
Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)
Description
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
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Time to onset of achieving HiSCR50
Time Frame
Up to week 16
Title
Percentage of participants achieving HiSCR75 at Week 16
Description
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
Time Frame
Week 16
Title
Percentage of participants achieving HiSCR90 at week 16
Description
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
Time Frame
Week 16
Title
Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16
Description
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient
Time Frame
Week 16
Title
Change in absolute score from Baseline in IHS4 at week 16
Time Frame
From Baseline to week 16
Title
Percentage of participants who experience a flare
Description
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.
Time Frame
Week 16
Title
Percentage of participants achieving IHS4-55
Description
IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from Baseline
Time Frame
Week 16
Title
Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions
Time Frame
Up to week 36
Title
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
Description
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)
Time Frame
Week 16
Title
Serum SAR442970 concentrations throughout the study
Time Frame
Up to 36 weeks
Title
Incidence of anti-SAR442970 antibody positive response throughout the study
Time Frame
Up to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial transparency email recommended (Toll free for US & Canada
Phone
800-633-1610
Ext
option 6
Email
contact-us@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
ForCare Clinical Research_Investigational Site Number: 8400006
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Studies, LTD.LLP_Investigational Site Number: 8400003
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number: 0360002
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number: 0360005
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360003
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0360001
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240001
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240002
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240004
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number: 1240007
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7580206
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7640881
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number: 3800001
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa

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