Hidradenitis Suppurativa
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Hidradenitis Suppurativa
ACT16852 Enrolling

Hidradenitis Suppurativa Clinical Research Trial (40 Weeks)


Treatment: Injection Age: 18 Years


Recruiting adults who are 18 to 70 years of age, inclusive with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year, to participate in this clinical research trial.  Must have HS lesions present in at least 2 distinct anatomic areas, have a total abscess and inflammatory nodule (AN) count of 3 or more, and a draining tunnel (fistula) count of 20 or less.

In addition, individuals must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, or exhibited recurrence after discontinuation of antibiotics, or demonstrated intolerance to antibiotics, or have a contraindication to oral antibiotics for treatment of their HS.  Other eligibility criteria apply.

Participants will receive investigational treatment (active study drug) or placebo, via injection.  Beginning at the Week 16 visit, all participants will receive active study drug.  Study treatment and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses will also be provided.

Study participation will last about 40 weeks and involve about 17 visits to the study centre.


Participating Locations

Participating Experts

Dr. Maryam Shayesteh Alam

Dermatologist

Dr. Peter Foley

Dermatologist

Dr. Wei Jing Loo

Dermatologist

Dr. Sanjay Siddha

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: February 25, 2024

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

ClinicalTrials.gov ID

NCT05849922

Sponsor

Sanofi

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.

  • Condition or Disease:

    Hidradenitis Suppurativa

  • Intervention/Treatment:

    Drug: SAR442970
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 70 Years (Adult)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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