Trial Outcomes & Findings for A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA) (NCT NCT04626297)
NCT ID: NCT04626297
Last Updated: 2023-10-17
Results Overview
Booster response to tetanus toxoid is defined as: ≥4-fold increase in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration if the pre-vaccination level was \>0.10 International units per milliliter (IU/mL) and ≤2.7 IU/mL; OR ≥2-fold increase in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination level was \>2.7 IU/mL; OR ≥4-fold increase in anti-tetanus toxoid IgG antibody concentration and a post-vaccination level ≥0.10 IU/mL if the pre-vaccination level was ≤0.10 IU/mL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
254 participants
Primary outcome timeframe
Week 16
Results posted on
2023-10-17
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneous (SC) injection once every two weeks (Q2W) from baseline to week 14.
|
Lebrikizumab 250 mg
Participants received a loading dose of 500 milligram (mg) lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
127
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
127
|
127
|
|
Overall Study
COMPLETED
|
88
|
113
|
|
Overall Study
NOT COMPLETED
|
39
|
14
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneous (SC) injection once every two weeks (Q2W) from baseline to week 14.
|
Lebrikizumab 250 mg
Participants received a loading dose of 500 milligram (mg) lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
|
Overall Study
Protocol Violation
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
20
|
6
|
|
Overall Study
Sponsor decision
|
2
|
1
|
Baseline Characteristics
A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
Baseline characteristics by cohort
| Measure |
Placebo
n=127 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=127 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 11.54 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 10.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants who received at least 1 dose of study drug, had no significant protocol deviations, and had non-missing sero-response data to Tdap vaccine.
Booster response to tetanus toxoid is defined as: ≥4-fold increase in anti-tetanus toxoid immunoglobulin G (IgG) antibody concentration if the pre-vaccination level was \>0.10 International units per milliliter (IU/mL) and ≤2.7 IU/mL; OR ≥2-fold increase in anti-tetanus toxoid IgG antibody concentration if the pre-vaccination level was \>2.7 IU/mL; OR ≥4-fold increase in anti-tetanus toxoid IgG antibody concentration and a post-vaccination level ≥0.10 IU/mL if the pre-vaccination level was ≤0.10 IU/mL
Outcome measures
| Measure |
Placebo
n=79 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=106 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Percentage of Participants Who Develop a Booster Response to Tetanus Toxoid 4 Weeks After Tdap (Tetanus-diphtheria-pertussis) Vaccine Administration
|
73.4 percentage of participants
|
73.6 percentage of participants
|
PRIMARY outcome
Timeframe: Week 16Population: All randomized participants who received at least 1 dose of study drug, had no significant protocol deviations, and had non-missing sero-response data to MCV.
Positive antibody response to Meningococcus C antigen as measured by group C serum bactericidal antibodies is defined as: post-vaccination rabbit complement serum bactericidal assay (rSBA) titer ≥4 times the lower limit of quantitation (LLOQ), if the pre-vaccination rSBA titer is less than the LLOQ; OR post-vaccination rSBA titer ≥4 times the pre-vaccination titer, if the pre-vaccination rSBA titer is greater than or equal to the LLOQ.
Outcome measures
| Measure |
Placebo
n=80 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=99 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Percentage of Participants Who Have Positive Antibody Response to Meningococcus C Antigen 4 Weeks After Meningococcal Conjugate Vaccine (MCV) Administration
|
75 percentage of participants
|
86.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants. Following a site audit and findings of non-compliance, two investigational sites with seven participants were excluded from the analysis as the data was considered unreliable.
The IGA measures the investigator's global assessment of the participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. Markov Chain Monte Carlo Multiple Imputation (MCMC-MI) was used to handle missing data.
Outcome measures
| Measure |
Placebo
n=122 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=125 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Percentage of Participants Achieving an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction of ≥2 Points From Baseline
|
18.9 percentage of participants
Interval 11.4 to 26.3
|
40.6 percentage of participants
Interval 31.8 to 49.4
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants. Following a site audit and findings of non-compliance, two investigational sites with seven participants were excluded from the analysis as the data was considered unreliable.
The EASI-75 is defined as a ≥ 75% improvement from baseline in the EASI score. EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. MCMC-MI was used to handle missing data.
Outcome measures
| Measure |
Placebo
n=122 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=125 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Percentage of Participants Achieving a ≥75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-75)
|
32.7 percentage of participants
Interval 23.5 to 41.9
|
58.0 percentage of participants
Interval 49.1 to 66.9
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants. Following a site audit and findings of non-compliance, two investigational sites with seven participants were excluded from the analysis as the data was considered unreliable.
The EASI-90 is defined as a ≥ 90% improvement from baseline in the EASI score. EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. MCMC-MI was used to handle missing data.
Outcome measures
| Measure |
Placebo
n=122 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=125 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Percentage of Participants Achieving ≥90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-90)
|
18.9 percentage of participants
Interval 11.3 to 26.4
|
39.2 percentage of participants
Interval 30.5 to 47.9
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants with a baseline pruritus NRS Score of at least 4. Following a site audit and findings of non-compliance, two investigational sites with seven participants were excluded from the analysis as the data was considered unreliable.
The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." MCMC-MI was used to handle missing data.
Outcome measures
| Measure |
Placebo
n=93 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=95 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Percentage of Participants Achieving ≥4-Point Improvement From Baseline in Pruritus Numeric Rating Scale (NRS) Score
|
33.2 percentage of participants
Interval 22.6 to 43.8
|
51.7 percentage of participants
Interval 41.2 to 62.3
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with evaluable BSA data at baseline and week 16. Following a site audit and findings of non-compliance, two investigational sites with seven participants were excluded from the analysis as the data was considered unreliable.
The BSA assessment estimates the extent of disease or skin involvement with respect to AD and is expressed as a percentage of body surface area. It was assessed for 4 body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100%. BSA was calculated using the participant's palm, 1 palm = 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 for head and neck (10%), 20 for upper extremities (20%), 30 for trunk, including axilla and groin (30%), and 40 for lower extremities, including buttocks (40%). Percent of BSA for a body region = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA for an individual is arithmetic mean of % BSA of all 4 body regions and ranges from 0% to 100% with higher values representing greater severity of AD.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=110 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Change From Baseline in Percent Body Surface Area (BSA)
|
-19.34 percentage of body surface area
Standard Error 1.882
|
-27.55 percentage of body surface area
Standard Error 1.719
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with evaluable sleep-loss score data at baseline and week 16. Following a site audit and findings of non-compliance, two investigational sites with seven participants were excluded from the analysis as the data was considered unreliable.
Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale \[0 (not at all) to 4 (unable to sleep at all)\]. Higher scores indicate a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary, and the week 16 score was calculated by averaging the daily scores from the previous 7 days and the average score was used to compute a change from baseline. MCMC-MI was used to handle missing data.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=111 Participants
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Change From Baseline in Sleep-Loss Score
|
-0.87 score on a scale
Standard Error 0.122
|
-1.35 score on a scale
Standard Error 0.107
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Lebrikizumab 250 mg
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=127 participants at risk
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=127 participants at risk
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage ii
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=127 participants at risk
Participants received placebo SC injection Q2W from baseline to week 14.
|
Lebrikizumab 250 mg
n=127 participants at risk
Participants received a loading dose of 500 mg lebrikizumab injection administered SC at baseline and week 2, and 250 mg Q2W from week 4 to 14.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site bruising
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pruritus
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pain
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Secretion discharge
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Vaccination site pain
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bacterial vaginosis
|
1.5%
1/67 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/72 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.4%
3/127 • Number of events 3 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
3.9%
5/127 • Number of events 5 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.5%
7/127 • Number of events 7 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Impetigo
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Kidney infection
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
3/127 • Number of events 3 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
4/127 • Number of events 4 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Staphylococcal infection
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/67 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 3 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Eosinophil count increased
|
0.79%
1/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Haemoglobin decreased
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
4/127 • Number of events 4 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Sleep inertia
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/67 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.4%
1/72 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.3%
8/127 • Number of events 10 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.7%
6/127 • Number of events 6 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.6%
2/127 • Number of events 2 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.79%
1/127 • Number of events 3 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/127 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Baseline Up To Week 26
All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60