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RIST4721 for Hidradenitis Suppurativa

Phase 2
Waitlist Available
Research Sponsored by Aristea Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of HS for at least 1 year prior to screening
HS lesions must be present in at least 2 distinct anatomic areas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights

Study Summary

This trial is studying RIST4721 to see if it is effective and safe in treating hidradenitis suppurativa.

Eligible Conditions
  • Hidradenitis Suppurativa

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with HS (Hidradenitis Suppurativa) for more than a year before the screening.
Select...
You must have HS lesions in at least two different parts of your body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of SAEs
Incidence of TEAEs
Secondary outcome measures
Proportion of Subjects Achieving HiSCR50 at Week 12

Side effects data

From 2019 Phase 2 trial • 35 Patients • NCT03988335
33%
Diarrhoea
20%
Urine odour abnormal
13%
Folliculitis
13%
Abnormal faeces
13%
Nausea
13%
Musculoskeletal stiffness
13%
Neutropenia
13%
Procedural pain
7%
Post procedural cellulitis
7%
Anxiety
7%
Concussion
7%
Increased appetite
7%
Bacterial test
7%
Cough
7%
Headache
7%
Abdominal pain
7%
Pain in extremity
7%
Osteoarthritis
7%
Decreased appetite
7%
Fatigue
7%
Blood glucose increased
7%
Blood triglycerides increased
7%
Hepatic enzyme increased
7%
Skin fissures
7%
Leukopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
RIST4721 300 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RIST4721 400 mgExperimental Treatment1 Intervention
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo: 4 placebo tablets once daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RIST4721
2019
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Aristea Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
152 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the status of RIST4721's FDA approval process?

"There is some data supporting the safety of RIST4721, but no data supporting efficacy. It received a score of 2."

Answered by AI

How many people are the most that will be taking part in this research project?

"The correct, as the information available on clinicaltrials.gov suggests that the clinical trial is recruiting patients. The trial was originally posted on 7/18/2022 and was last edited on 9/28/2022. The clinical trial is searching for 33 patients between 10 sites."

Answered by AI
~9 spots leftby Mar 2025