Trial Outcomes & Findings for A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS) (NCT NCT05348681)
NCT ID: NCT05348681
Last Updated: 2023-06-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline to Week 12 (or end of study participation)
Results posted on
2023-06-13
Participant Flow
Participant milestones
| Measure |
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
|
Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
8
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
| Measure |
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
|
Placebo
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
Study terminated by Sponsor
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Other
|
2
|
1
|
Baseline Characteristics
A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
Baseline characteristics by cohort
| Measure |
RIST4721 400 mg
n=17 Participants
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
|
Placebo
n=8 Participants
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
7 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12 (or end of study participation)Population: Subjects with at least one TEAE
Outcome measures
| Measure |
RIST4721 400 mg
n=17 Participants
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
|
Placebo
n=8 Participants
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
|---|---|---|
|
Incidence of TEAEs
|
9 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12 (or end of study participation)Population: Subjects with at least one SAE
Outcome measures
| Measure |
RIST4721 400 mg
n=17 Participants
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
|
Placebo
n=8 Participants
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
|---|---|---|
|
Incidence of SAEs
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Subjects who completed Week 12
Outcome measures
| Measure |
RIST4721 400 mg
n=7 Participants
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
|
Placebo
n=3 Participants
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
|---|---|---|
|
Proportion of Subjects Achieving HiSCR50 at Week 12
|
3 Participants
|
2 Participants
|
Adverse Events
RIST4721 400 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RIST4721 400 mg
n=17 participants at risk
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
|
Placebo
n=8 participants at risk
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
|---|---|---|
|
Nervous system disorders
Migraine
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/17 • From ICF signature to end of study participation.
|
12.5%
1/8 • Number of events 1 • From ICF signature to end of study participation.
|
Other adverse events
| Measure |
RIST4721 400 mg
n=17 participants at risk
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
|
Placebo
n=8 participants at risk
Placebo: 4 placebo tablets once daily for 12 weeks
Placebo: Matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • From ICF signature to end of study participation.
|
12.5%
1/8 • Number of events 1 • From ICF signature to end of study participation.
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
General disorders
Chest pain
|
0.00%
0/17 • From ICF signature to end of study participation.
|
12.5%
1/8 • Number of events 1 • From ICF signature to end of study participation.
|
|
Infections and infestations
COVID-19
|
11.8%
2/17 • Number of events 2 • From ICF signature to end of study participation.
|
12.5%
1/8 • Number of events 1 • From ICF signature to end of study participation.
|
|
Infections and infestations
Chlamydial infection
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • From ICF signature to end of study participation.
|
25.0%
2/8 • Number of events 2 • From ICF signature to end of study participation.
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Investigations
Liver function test increased
|
11.8%
2/17 • Number of events 2 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/17 • From ICF signature to end of study participation.
|
12.5%
1/8 • Number of events 1 • From ICF signature to end of study participation.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Nervous system disorders
Carotid artery aneurysm
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Nervous system disorders
Restless leg syndrome
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Nervous system disorders
Sciatica
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
12.5%
1/8 • Number of events 1 • From ICF signature to end of study participation.
|
|
Renal and urinary disorders
Urine odour abnormal
|
17.6%
3/17 • Number of events 3 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Number of events 1 • From ICF signature to end of study participation.
|
0.00%
0/8 • From ICF signature to end of study participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place