Your session is about to expire
← Back to Search
Unknown
SAR442970 for Hidradenitis Suppurativa (HS OBTAIN Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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, one of which must be Hurley Stage II or Hurley Stage III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 36
Awards & highlights
HS OBTAIN Trial Summary
This trial is testing a new drug to treat adults with moderate-severe hidradenitis suppurativa (HS). Its safety & effectiveness will be studied.
Who is the study for?
Adults with moderate to severe hidradenitis suppurativa (HS) who have lesions in at least two areas and an inadequate response to antibiotics can join. They must not have had certain treatments, have a CRP >3 mg/L, and be judged as needing systemic treatment. Exclusions include adverse reactions to anti-TNF therapy, allergies that affect study participation, breastfeeding or planning pregnancy during the study, substance abuse history, serious infections or immunosuppression.Check my eligibility
What is being tested?
The trial is testing SAR442970 against a placebo in adults with HS. It aims to see if SAR442970 is effective and safe for treating this skin condition. Participants will randomly receive either the actual drug or a placebo without knowing which one they are getting.See study design
What are the potential side effects?
While specific side effects of SAR442970 aren't listed here, common side effects for drugs treating HS may include pain at injection site, infection risk increase, headache, nausea and potential allergic reactions.
HS OBTAIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had symptoms of hidradenitis suppurativa for at least 1 year.
Select...
I have HS lesions in 2 different areas, with one area being moderate or severe.
HS OBTAIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)
Secondary outcome measures
Change in absolute score from Baseline in IHS4 at week 16
Incidence of anti-SAR442970 antibody positive response throughout the study
Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions
+8 moreHS OBTAIN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR442970Experimental Treatment1 Intervention
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).
Group II: PlaceboPlacebo Group1 Intervention
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).
Find a Location
Who is running the clinical trial?
SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,866 Total Patients Enrolled
2 Trials studying Hidradenitis Suppurativa
183 Patients Enrolled for Hidradenitis Suppurativa
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,724 Total Patients Enrolled
1 Trials studying Hidradenitis Suppurativa
84 Patients Enrolled for Hidradenitis Suppurativa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am breastfeeding or might become pregnant during the study.I have tried oral antibiotics for HS without success, had HS return after stopping them, can't tolerate them, or can't take them for medical reasons.I have not used biologic or small molecule immunosuppressives, or I have used TNF blockers.My doctor thinks I should get treatment that affects my whole body.I have had a solid organ transplant.I have had my spleen removed.I had cancer before, but it was either skin cancer treated completely or another type that did not spread.I had a bad reaction to anti-TNF therapy that means I can't take it again.I have HS lesions in 2 different areas, with one area being moderate or severe.You need to have at least 3 abscesses and inflammatory nodules at the start of the study.I have not had thoughts or attempts of suicide in the past 6 months.I haven't had a live vaccine in the last 12 weeks or a killed vaccine in the last 2 weeks.Your C-reactive protein (CRP) level must be higher than 3 mg/L during the screening visit.I have a history of diseases that affect the protective covering of nerves.You must have 20 or fewer draining tunnels at the start of the study.I have had symptoms of hidradenitis suppurativa for at least 1 year.I have had serious infections recently or that keep coming back.I have had serious heart failure in the past.I do not have any skin conditions that could affect HS assessment.I have a history of or currently have a weakened immune system.I have an inflammatory condition that is not HS.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: SAR442970
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent can SAR442970 be detrimental to human health?
"Our experts at Power rated SAR442970's safety as a 2, seeing as there is limited data relating to its efficacy but some evidence indicating that it is not dangerous."
Answered by AI
Do I meet the requirements for enrollment in this trial?
"The current trial seeks to include 114 patients who are afflicted with hidradenitis suppurativa and aged between 18-70."
Answered by AI
Is this trial open to elderly participants?
"The terms of participation in this trial stipulate that patients must be between the ages 18 to 70. Additionally, there are 3 specific experimental arms targeting individuals under 18 and 32 for seniors aged 65 years or more."
Answered by AI
Is enrollment open for this trial at present?
"Indeed, the information available on clinicaltrials.gov displays that this medical trial is recruiting patients. The initial post was made on June 15th 2023 and subsequently updated a month later in June 1st 2023; 114 individuals from 2 locations are needed for enrollment."
Answered by AI
What is the upper bound of individuals involved in this experiment?
"Yes, the clinicaltrials.gov website reveals that enrollment for this research is actively ongoing. The trial was initially posted on June 15th 2023 and edited as recently as June 1st 2023. There are 114 slots available across 2 participating sites in total."
Answered by AI
Who else is applying?
What site did they apply to?
Clinical Partners, LLC Site Number : 8400010
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger