A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

Phase 2TerminatedNCT05348681

Aristea Therapeutics, Inc.25 enrolled

Overview

A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

RIST4721DRUG

RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets

PlaceboDRUG

Matching placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of HS for at least 1 year prior to screening * HS lesions must be present in at least 2 distinct anatomic areas * A total AN count (sum of abscesses and inflammatory nodules) \> 6 across all anatomical sites at both the screening and baseline visits * Willing to use contraception for the duration of the study Exclusion Criteria: * Presence of other skin conditions which may interfere with study assessments * Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening * Body Mass Index (BMI) \>48kg/m2 * Breastfeeding or pregnant

Locations (12)

Cahaba Dermatology & Skin Center

Birmingham, Alabama, United States

Investigate MD, LLC

Scottsdale, Arizona, United States

USC IDS Pharmacy

Los Angeles, California, United States

Outcomes

Primary Outcomes

Incidence of TEAEs

Time frame: Baseline to Week 12 (or end of study participation)

Incidence of SAEs

Time frame: Baseline to Week 12 (or end of study participation)

Secondary Outcomes

Proportion of Subjects Achieving HiSCR50 at Week 12

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

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