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A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (ZEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06028230
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : March 25, 2024
Sponsor:
Collaborator:
Kymera Therapeutics, Inc.
Information provided by (Responsible Party):
Sanofi

Brief Summary:

This is a parallel, Phase 2, 2-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years.

Study details include:

  • Screening period: up to 4 weeks (30 days)
  • Treatment duration: up to 16 weeks
  • Follow-up period: up to 4 weeks
  • Total study duration: up to 24 weeks
  • Number of visits: 14

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: SAR444656 (KT-474) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Actual Study Start Date : September 29, 2023
Estimated Primary Completion Date : February 13, 2025
Estimated Study Completion Date : March 14, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAR444656
Participants will receive SAR444656 orally
Drug: SAR444656 (KT-474)
Oral Tablet

Placebo Comparator: Placebo
Participants will receive placebo orally
Drug: Placebo
Oral Tablet




Primary Outcome Measures :
  1. Percent change from baseline in total abscess and inflammatory nodule (AN) count [ Time Frame: Week 16 ]
    The AN count is the sum of the abscess count and inflammatory nodule count at any given clinical assessment. It is derived from the lesion counts count obtained as part of the HS clinical parameters.


Secondary Outcome Measures :
  1. Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50) [ Time Frame: Week 16 ]
  2. Proportion of participants achieving AN count ≤2 [ Time Frame: Week 16 ]
  3. Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) [ Time Frame: Week 16 ]
  4. Proportion of participants with improvement from baseline in Hurley Stage [ Time Frame: Week 16 ]
  5. Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline) [ Time Frame: Week 16 ]
  6. Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS) [ Time Frame: Week 16 ]
  7. Proportion of participants achieving improvement defined as at least 30% reduction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS [ Time Frame: Week 16 ]
  8. Change from baseline in the amount of analgesic [ Time Frame: Up to Week 16 ]
  9. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs [ Time Frame: Up to Week 20 ]
  10. Plasma SAR444656 concentration [ Time Frame: Up to Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
  • Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III.
  • Participant must have had an inadequate response to at least a 3-month treatment of an oral antibiotic for treatment of HS as assessed by the Investigator.
  • Participant must have a total AN count of ≥5 at the baseline visit.
  • Participant must have a draining tunnel count of ≤20 at the baseline visit.
  • Participant must have a CRP >3 mg/L obtained at screening.
  • Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol.
  • Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
  • Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
  • Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  • Participant with history of solid organ transplant.
  • Participant with history of splenectomy.
  • Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed.
  • Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS
  • Participant with family history of sudden death or long QT syndrome.
  • Participant with history of congenital or drug-induced long QT syndrome.
  • Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.
  • Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
  • Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
  • Participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite antihypertensive medication.
  • Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
  • Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17 therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study population. Furthermore, this 20% of biologic-experienced participants must fulfilled one or more of the following conditions:

    • Discontinued due to treatment related toxicity and/or
    • Discontinuation is not related to lack or loss of therapeutic response.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028230


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Sanofi
Kymera Therapeutics, Inc.
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT06028230    
Other Study ID Numbers: ACT17841
2023-504328-25 ( Registry Identifier: CTIS )
U1111-1285-8790 ( Registry Identifier: ICTRP )
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: March 25, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration