Hidradenitis SuppurativaPhase 2NCT05348681
A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
A Phase 2 study testing RIST4721 in people with Hidradenitis Suppurativa, run by Aristea Therapeutics, Inc. at 12 sites in 2 countries.
Trial summary
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- RIST4721
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 18 Jul 2022to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
Cahaba Dermatology & Skin Center
Birmingham, Alabama, 35244
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
Wright State Physicians
Fairborn, Ohio, 45324
USC IDS Pharmacy
Los Angeles, California, 90033
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
The Indiana Clinical Trials Center, P.C.
Plainfield, Indiana, 46168
Progressive Clinical Research
San Antonio, Texas, 78213
Investigate MD, LLC
Scottsdale, Arizona, 85255
ForCare Clinical Research
Tampa, Florida, 33613
Canada2 sites
SKiN Health
Cobourg, Ontario, K9A 0Z4
Enverus Medical Research
Surrey, British Columbia, V3V 0C6
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
- Conditions
- Hidradenitis Suppurativa
- Being tested
- RIST4721, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIST4721Drug
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| RIST4721 400 mg | Experimental | RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks Receives: Drug: RIST4721 |
| Placebo | Placebo comparator | Placebo: 4 placebo tablets once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs
Measured: Baseline to Week 12 (or end of study participation)
Incidence of SAEs
Measured: Baseline to Week 12 (or end of study participation)
Secondary outcomes (1)
Proportion of Subjects Achieving HiSCR50 at Week 12
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start18 Jul 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Due to safety findings in ongoing Phase 2 trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristea Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348681
- Sponsor's protocol ID
- RIST4721-221
- Status last verified
- May 2023
- First submitted
- 19 Apr 2022
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT05348681
- Acronym / sponsor ID
- RIST4721-221
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to safety findings in ongoing Phase 2 trials.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aristea Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIST4721 400 mg | Experimental | Drug: RIST4721RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: 4 placebo tablets once daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIST4721RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets | Drug | RIST4721 400 mg |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
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)
1 secondary outcome
Proportion of Subjects Achieving HiSCR50 at Week 12
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RIST4721 in people with Hidradenitis Suppurativa, run by Aristea Therapeutics, Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (time frame: Baseline to Week 12 (or end of study participation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.