Trial Outcomes & Findings for A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis (NCT NCT05870865)
NCT ID: NCT05870865
Last Updated: 2025-05-16
Results Overview
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
144 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
ASN008 1.25%
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Randomized
STARTED
|
36
|
36
|
36
|
36
|
|
Randomized
COMPLETED
|
34
|
32
|
32
|
33
|
|
Randomized
NOT COMPLETED
|
2
|
4
|
4
|
3
|
|
Treatment Period
STARTED
|
34
|
32
|
32
|
33
|
|
Treatment Period
COMPLETED
|
33
|
29
|
28
|
30
|
|
Treatment Period
NOT COMPLETED
|
1
|
3
|
4
|
3
|
Reasons for withdrawal
| Measure |
ASN008 1.25%
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Randomized
Did not receive study treatment
|
2
|
4
|
4
|
3
|
|
Treatment Period
Adverse Event
|
1
|
1
|
1
|
1
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
2
|
0
|
|
Treatment Period
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
ASN008 1.25%
n=34 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=32 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=32 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=33 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
Total
n=131 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 15.45 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 12.54 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 15.95 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 16.04 • n=4 Participants
|
44.9 years
STANDARD_DEVIATION 15.09 • n=21 Participants
|
|
Sex/Gender, Customized
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: White
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Black or African American
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race: Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Modified Intent to Treat
Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4
Outcome measures
| Measure |
ASN008 1.25%
n=30 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=30 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=26 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=31 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Daily Peak Pruritus Numerical Rating Scale (NRS)
|
-45.6 percent change
Standard Error 5.04
|
-55.8 percent change
Standard Error 5.13
|
-48.3 percent change
Standard Error 5.2
|
-49.9 percent change
Standard Error 4.99
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Modified Intent to Treat
Pruritus response defined as 7-day average of daily peak pruritus NRS reduction greater than or equal to 4 points from Baseline to Week 4
Outcome measures
| Measure |
ASN008 1.25%
n=34 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=32 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=32 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=33 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS
|
12 Participants
|
22 Participants
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Modified Intent to Treat
This outcome measure evaluates the change and percent change in the Eczema Area and Severity Index (EASI) score from Baseline to Week 4. The EASI score measures the extent and severity of eczema across four body regions: head/neck, trunk, upper limbs, and lower limbs. Two components are assessed: severity of erythema, edema/papulation, excoriation, and lichenification (each scored 0 to 3, with 0 = none and 3 = severe) and the surface area affected (scored 0 to 6, with 0 = no involvement and 6 = 90%-100% involvement). Subscale scores are combined using weighted multipliers for each region (head/neck 0.1, upper limbs 0.2, trunk 0.3, lower limbs 0.4) to calculate the total score. The EASI is a composite score ranging from 0 (no eczema) to 72 (maximum severity and extent). Scores are summed to account for the severity of lesions and the percentage of body surface area (BSA) affected in each region.
Outcome measures
| Measure |
ASN008 1.25%
n=32 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=28 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=25 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=30 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
|
-2.7 score on a scale
Standard Error 0.40
|
-3.5 score on a scale
Standard Error 0.43
|
-2.6 score on a scale
Standard Error 0.45
|
-3.4 score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Modified Intent to Treat
Change from Baseline in total BSA at week 4.
Outcome measures
| Measure |
ASN008 1.25%
n=32 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=28 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=25 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=30 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Mean Change From Baseline in Total Body Surface Area (BSA)
|
-2.6 Percentage
Standard Error 0.56
|
-2.9 Percentage
Standard Error 0.59
|
-1.5 Percentage
Standard Error 0.60
|
-2.4 Percentage
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Modified Intent to Treat
This outcome measure evaluates the change in the the Patient-Oriented Eczema Measure (POEM) score from Baseline to Week 4.The POEM is a self-assessment tool that evaluates eczema severity based on patient-reported symptoms over the previous week. It includes 7 questions addressing common symptoms: itch, sleep disturbance, bleeding, weeping, cracking, flaking, and dryness. Each question is scored on a scale from 0 to 4 based on frequency (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = every day). The scores are summed to generate a total score ranging from 0 to 28. Scores are interpreted as follows: 0-2 = clear or almost clear, 3-7 = mild eczema, 8-16 = moderate eczema, 17-24 = severe eczema, and 25-28 = very severe eczema. Higher scores indicate a greater symptom burden and worse disease severity.
Outcome measures
| Measure |
ASN008 1.25%
n=31 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=28 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=25 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=29 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)
|
-5.0 score on a scale
Standard Error 1.04
|
-7.8 score on a scale
Standard Error 1.08
|
-6.3 score on a scale
Standard Error 1.11
|
-6.4 score on a scale
Standard Error 1.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 4ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 4ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 56Population: Safety
Number of participants who experienced a TEAE.
Outcome measures
| Measure |
ASN008 1.25%
n=34 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=32 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=32 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=33 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
12 Participants
|
14 Participants
|
11 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 56Population: Safety
Number of participants who experienced an IP-related TEAE.
Outcome measures
| Measure |
ASN008 1.25%
n=34 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=32 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=32 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=33 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Number of Investigational Product (IP)-Related TEAEs
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 56Population: Safety
Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days)
Outcome measures
| Measure |
ASN008 1.25%
n=34 Participants
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=32 Participants
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=32 Participants
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=33 Participants
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Incidence of TEAEs Leading to Treatment Discontinuation
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
ASN008 1.25%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
ASN008 2.5%
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
ASN008 5%
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
ASN008 Matching Vehicle
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASN008 1.25%
n=34 participants at risk
ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 2.5%
n=32 participants at risk
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 5%
n=32 participants at risk
ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
|
ASN008 Matching Vehicle
n=33 participants at risk
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm\^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
General disorders
Application Site Pain
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
COVID-19
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Eczema Impetiginous
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Gastroenteritis viral
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Impetigo
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Influenza
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
9.4%
3/32 • Number of events 3 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
6.1%
2/33 • Number of events 2 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Pyuria
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Injury, poisoning and procedural complications
Heat Exhaustion
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Investigations
Blood Creatine Phosphokinase increased
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Investigations
Blood Iron Decreased
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Investigations
Protein Urine Present
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
6.2%
2/32 • Number of events 2 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Investigations
Urine Ketone Body Present
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Investigations
Urine Leukocyte Esterase Positive
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
2/34 • Number of events 2 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
6.2%
2/32 • Number of events 2 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 3 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
9.4%
3/32 • Number of events 3 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
2.9%
1/34 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.1%
1/32 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/33 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.00%
0/34 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
0.00%
0/32 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
3.0%
1/33 • Number of events 1 • Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place