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

Aristea Therapeutics, Inc.12 sites in 2 countries25 target enrollmentJuly 18, 2022

ConditionsHidradenitis Suppurativa

InterventionsRIST4721 Placebo

DrugsRIST4721 Placebo

Overview

Phase: Phase 2
Intervention: RIST4721
Conditions: Hidradenitis Suppurativa
Sponsor: Aristea Therapeutics, Inc.
Enrollment: 25
Locations: 12
Primary Endpoint: Incidence of TEAEs
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 18, 2022

End Date

February 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aristea Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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