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A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

Primary Purpose

Hidradenitis Suppurativa

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RIST4721
Placebo
Sponsored by
Aristea Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cahaba Dermatology & Skin Center
  • Investigate MD, LLC
  • USC IDS Pharmacy
  • Florida Academic Centers Research and Education, LLC
  • ForCare Clinical Research
  • The Indiana Clinical Trials Center, P.C.
  • Beth Israel Deaconess Medical Center
  • Wright State Physicians
  • Progressive Clinical Research
  • Virginia Clinical Research, Inc.
  • Enverus Medical Research
  • SKiN Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RIST4721 400 mg

Placebo

Arm Description

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

Placebo: 4 placebo tablets once daily for 12 weeks

Outcomes

Primary Outcome Measures

Incidence of TEAEs
Incidence of SAEs

Secondary Outcome Measures

Proportion of Subjects Achieving HiSCR50 at Week 12

Full Information

First Posted
April 19, 2022
Last Updated
May 18, 2023
Sponsor
Aristea Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05348681
Brief Title
A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
Official Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to safety findings in ongoing Phase 2 trials.
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aristea Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIST4721 400 mg
Arm Type
Experimental
Arm Description
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: 4 placebo tablets once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
RIST4721
Intervention Description
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Incidence of TEAEs
Time Frame
Baseline to Week 12 (or end of study participation)
Title
Incidence of SAEs
Time Frame
Baseline to Week 12 (or end of study participation)
Secondary Outcome Measure Information:
Title
Proportion of Subjects Achieving HiSCR50 at Week 12
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cahaba Dermatology & Skin Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Investigate MD, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
USC IDS Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Florida Academic Centers Research and Education, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
The Indiana Clinical Trials Center, P.C.
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
SKiN Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 0Z4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

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