A Phase 2 interventional study of RIST4721 and Placebo in Hidradenitis Suppurativa, sponsored by Aristea Therapeutics, Inc.. Terminated at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by Aristea Therapeutics, Inc. · Phase 2, Interventional, and Treatment
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 25 is below the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Aristea Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
Drug: RIST4721
Placebo: 4 placebo tablets once daily for 12 weeks
Drug: Placebo
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
Matching placebo
Incidence of TEAEs
Time frame: Baseline to Week 12 (or end of study participation)
Incidence of SAEs
Time frame: Baseline to Week 12 (or end of study participation)
Proportion of Subjects Achieving HiSCR50 at Week 12
Time frame: Baseline to Week 12
| Milestone | RIST4721 400 mg | Placebo |
|---|---|---|
| Started | 17 | 8 |
| Completed | 4 | 2 |
| Not completed | 13 | 6 |
| Withdrew: Study terminated by sponsor | 8 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Other | 2 | 1 |
| Participants | RIST4721 400 mg | Placebo |
|---|---|---|
| Incidence of TEAEs | 9 | 4 |
| Participants | RIST4721 400 mg | Placebo |
|---|---|---|
| Incidence of SAEs | 1 | 1 |
| Participants | RIST4721 400 mg | Placebo |
|---|---|---|
| Proportion of Subjects Achieving HiSCR50 at Week 12 | 3 | 2 |
Collected over From ICF signature to end of study participation.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RIST4721 400 mg | 0/17 (0%) | 1/17 (5.9%) | 9/17 (52.9%) |
| Placebo | 0/8 (0%) | 1/8 (12.5%) | 4/8 (50%) |
| Event | RIST4721 400 mg | Placebo |
|---|---|---|
| Obstructive pancreatitisGastrointestinal disorders | 0/17 | 1/8 |
| MigraineNervous system disorders | 1/17 | 0/8 |
| Event | RIST4721 400 mg | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 0/17 | 2/8 |
| Urine odour abnormalRenal and urinary disorders | 3/17 | 0/8 |
| DiarrhoeaGastrointestinal disorders | 0/17 | 1/8 |
| Chest painGeneral disorders | 0/17 | 1/8 |
| COVID-19Infections and infestations | 2/17 | 1/8 |
| HypertriglyceridaemiaMetabolism and nutrition disorders | 0/17 | 1/8 |
| SciaticaNervous system disorders | 1/17 | 1/8 |
| Liver function test increasedInvestigations | 2/17 | 0/8 |
| Abdominal pain lowerGastrointestinal disorders | 1/17 | 0/8 |
| FatigueGeneral disorders | 1/17 | 0/8 |
| Age, Categorical(Participants) | RIST4721 400 mg | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 8 | 25 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | RIST4721 400 mg | Placebo | Total |
|---|---|---|---|
| Female | 15 | 7 | 22 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | RIST4721 400 mg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 14 | 5 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | RIST4721 400 mg | Placebo | Total |
|---|---|---|---|
| Canada | 3 | 1 | 4 |
| United States | 14 | 7 | 21 |
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Aristea Therapeutics, Inc.