Trial Outcomes & Findings for A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP) (NCT NCT05194839)
NCT ID: NCT05194839
Last Updated: 2023-06-29
Results Overview
In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2023-06-29
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
|
RIST4721 200 mg
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo 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
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
26
|
|
Overall Study
COMPLETED
|
12
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Baseline characteristics by cohort
| Measure |
RIST4721 400 mg
n=27 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
|
RIST4721 200 mg
n=26 Participants
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
|
Placebo
n=26 Participants
Placebo: 4 placebo tablets once daily for 12 weeks
|
Total
n=79 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12In the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI), the left palm, right palm, left foot, and right foot are assessed based on 3 target symptoms: erythema, desquamation (scaling), and pustules, as seen on the day of the examination. The severity of each sign is assessed using a 5-point scale (0 = not present, 1 = slight, 3 = moderate, 4 = severe, 5 = very severe). The affected area within a given anatomic site (left palm, right palm, left foot, and right foot) is estimated as a percentage of the total area of that anatomic site and assigned a numerical value according to the degree of PPP involvement (0 = no involvement, 2 = 10 to less than 30% involvement, 3 = 30 to less than 50% involvement, 4 = 50 to less than 70% involvement, 5 = 70 to less than 90% involvement, 6 = 90 to less than 100% involvement). PPPASI score for palms and soles is obtained using a formula and can vary from 0 (absence of disease) to 72 (most severe disease).
Outcome measures
| Measure |
RIST4721 400 mg
n=12 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
|
RIST4721 200 mg
n=13 Participants
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
|
Placebo
n=12 Participants
Placebo: 4 placebo tablets once daily for 12 weeks
|
|---|---|---|---|
|
Proportion of Subjects Achieving a 50% Reduction in PPPASI Score
|
6 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 12Outcome measures
Outcome data not reported
Adverse Events
RIST4721 400 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
RIST4721 200 mg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RIST4721 400 mg
n=27 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
|
RIST4721 200 mg
n=26 participants at risk
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
|
Placebo
n=26 participants at risk
Placebo: 4 placebo tablets once daily for 12 weeks
|
|---|---|---|---|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Number of events 1 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Number of events 1 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
Other adverse events
| Measure |
RIST4721 400 mg
n=27 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
|
RIST4721 200 mg
n=26 participants at risk
RIST4721 200 mg: 2 active (100 mg) tablets + 2 placebo tablets once daily for 12 weeks
RIST4721: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets
|
Placebo
n=26 participants at risk
Placebo: 4 placebo tablets once daily for 12 weeks
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
11.5%
3/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
15.4%
4/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Urinary Tract Infection
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Covid-19
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
4/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
2/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
7.7%
2/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
C-reactive protein increased
|
7.4%
2/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
7.7%
2/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
General disorders
Fatigue
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Renal and urinary disorders
Urine odor abnormal
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
11.5%
3/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Vascular disorders
Hypertension
|
7.4%
2/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Asymptomatic COVID-19
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Bacterial vaginosis
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Cystitis bacterial
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Furuncle
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Tonsillitis
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
Weight decreased
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
White blood cell count increased
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar pustulosis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Invertebral disc protrusion
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Nervous system disorders
Vertigo
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
General disorders
Xerosis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Renal and urinary disorders
Haematuria
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Eye disorders
Blepharitis
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Eye disorders
Vision blurred
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
7.7%
2/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
3.7%
1/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/27 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
3.8%
1/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
0.00%
0/26 • Baseline through end of Week 12 (blinded treatment) and up to 4 weeks of follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place