A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

Sponsor
Aristea Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05348681
Collaborator
(none)
33
5
2
11
6.6
0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa
Anticipated Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: RIST4721 400 mg

RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks

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

Placebo Comparator: Placebo

Placebo: 4 placebo tablets once daily for 12 weeks

Drug: Placebo
Matching placebo

Outcome Measures

Primary Outcome Measures

  1. Incidence of TEAEs and SAEs [Baseline to Week 12]

Secondary Outcome Measures

  1. Proportion of subjects achieving HiSCR50 at Week 12 [Baseline to Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cahaba Dermatology & Skin Center Birmingham Alabama United States 35244
2 Investigate MD, LLC Scottsdale Arizona United States 85255
3 Florida Academic Centers Research and Education, LLC Coral Gables Florida United States 33134
4 Virginia Clinical Research, Inc. Norfolk Virginia United States 23502
5 SKiN Health Cobourg Ontario Canada K9A 0Z4

Sponsors and Collaborators

  • Aristea Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aristea Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05348681
Other Study ID Numbers:
  • RIST4721-221
First Posted:
Apr 27, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022