Hidradenitis Suppurativa
Conditions
Brief summary
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
Interventions
DRUGRIST4721
RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
DRUGPlacebo
Matching placebo
Sponsors
Aristea Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of Subjects Achieving HiSCR50 at Week 12 | Baseline to Week 12 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RIST4721 400 mg RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks
RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets | 17 |
| Placebo Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo | 8 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Study terminated by Sponsor | 8 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | RIST4721 400 mg | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 8 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 5 Participants | 19 Participants |
| Region of Enrollment Canada | 3 participants | 1 participants | 4 participants |
| Region of Enrollment United States | 14 participants | 7 participants | 21 participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 8 |
| other Total, other adverse events | 9 / 17 | 4 / 8 |
| serious Total, serious adverse events | 1 / 17 | 1 / 8 |
Outcome results
Primary
Incidence of SAEs
Time frame: Baseline to Week 12 (or end of study participation)
Population: Subjects with at least one SAE
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIST4721 400 mg | Incidence of SAEs | 1 Participants |
| Placebo | Incidence of SAEs | 1 Participants |
Primary
Incidence of TEAEs
Time frame: Baseline to Week 12 (or end of study participation)
Population: Subjects with at least one TEAE
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIST4721 400 mg | Incidence of TEAEs | 9 Participants |
| Placebo | Incidence of TEAEs | 4 Participants |
Secondary
Proportion of Subjects Achieving HiSCR50 at Week 12
Time frame: Baseline to Week 12
Population: Subjects who completed Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIST4721 400 mg | Proportion of Subjects Achieving HiSCR50 at Week 12 | 3 Participants |
| Placebo | Proportion of Subjects Achieving HiSCR50 at Week 12 | 2 Participants |