NCT05348681

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_2

Geographic Reach
2 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 13, 2023

Completed
Last Updated

June 13, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

April 19, 2022

Results QC Date

May 18, 2023

Last Update Submit

May 18, 2023

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (2)

  • Incidence of TEAEs

    Baseline to Week 12 (or end of study participation)

  • Incidence of SAEs

    Baseline to Week 12 (or end of study participation)

Secondary Outcomes (1)

  • Proportion of Subjects Achieving HiSCR50 at Week 12

    Baseline to Week 12

Study Arms (2)

RIST4721 400 mg

EXPERIMENTAL

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

Drug: RIST4721

Placebo

PLACEBO COMPARATOR

Placebo: 4 placebo tablets once daily for 12 weeks

Drug: Placebo

Interventions

RIST4721DRUG

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

RIST4721 400 mg
PlaceboDRUG

Matching placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cahaba Dermatology & Skin Center

Birmingham, Alabama, 35244, United States

Location

Investigate MD, LLC

Scottsdale, Arizona, 85255, United States

Location

USC IDS Pharmacy

Los Angeles, California, 90033, United States

Location

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, 33134, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

The Indiana Clinical Trials Center, P.C.

Plainfield, Indiana, 46168, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Enverus Medical Research

Surrey, British Columbia, V3V 0C6, Canada

Location

SKiN Health

Cobourg, Ontario, K9A 0Z4, Canada

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Results Point of Contact

Title
Aristea Therapeutics
Organization
Aristea Therapeutics
info@aristeatx.com
858-465-6142

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 27, 2022

Study Start

July 18, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

June 13, 2023

Results First Posted

June 13, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)US(10)