Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (NCT NCT04250350)

Last Updated: 2023-02-24

Results Overview

The percentage of participants who discontinued from study treatment due to 1 or more AEs assessed is summarized cumulatively. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

206 participants

Primary outcome timeframe

Week 52

Results posted on

2023-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Lebrikizumab 250 mg Participants received two subcutaneous (SC) injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Overall Study STARTED	206
Overall Study COMPLETED	172
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Lebrikizumab 250 mg Participants received two subcutaneous (SC) injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Overall Study Withdrawal by Subject	13
Overall Study Lost to Follow-up	8
Overall Study Adverse Event	5
Overall Study Lack of Efficacy	4
Overall Study Physician Decision	1
Overall Study Participant moved out of the country/non-compliance	3

Baseline Characteristics

Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lebrikizumab 250 mg n=206 Participants Participants received 250 mg Lebrikizumab SC at baseline and Week 2. From Week 4 onwards, all participants received 250 mg lebrikizumab SC every 2 weeks up to (but not including) Week 52.
Age, Categorical <=18 years	206 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14.6 years STANDARD_DEVIATION 1.79 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants
Race (NIH/OMB) White	138 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment Canada	20 Participants n=5 Participants
Region of Enrollment United States	111 Participants n=5 Participants
Region of Enrollment Poland	63 Participants n=5 Participants
Region of Enrollment Australia	12 Participants n=5 Participants
Weight <60 kg	92 Participants n=5 Participants
Weight >=60 - <100 kg	95 Participants n=5 Participants
Weight >= 100 kg	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: All enrolled participants.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=206 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs)	2.4 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: All participants with evaluable data for IGA score of 0 or 1.

The IGA measures the investigator's global assessment of the participant's overall severity of their 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.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=206 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline	62.6 percentage of participants Interval 55.6 to 69.6

SECONDARY outcome

Timeframe: Week 52

Population: All participants with evaluable data for EASI-75.

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs 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: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=206 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75)	81.9 percentage of participants Interval 76.5 to 87.4

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants with evaluable data for EASI score.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=206 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Percentage Change From Baseline in EASI Score	-86.0 percentage change Interval -89.1 to -83.0

SECONDARY outcome

Timeframe: Week 52

Population: All participants with evaluable data for EASI-50.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=206 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score)	94.4 percentage of participants Interval 91.1 to 97.7

SECONDARY outcome

Timeframe: Week 52

Population: All participants with evaluable data for EASI-90.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=206 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score)	61.4 percentage of participants Interval 54.5 to 68.3

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants with evaluable data for BSA.

The BSA affected by AD will be assessed for 4 separate 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% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=172 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Change From Baseline in Body Surface Area (BSA)	-37.63 percentage of body surface area Standard Deviation 21.071

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants with evaluable data for PROMIS Anxiety.

PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants ≤17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-Scores (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=170 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety	-6.34 T-score Standard Deviation 9.979

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants evaluable data for PROMIS Depression.

PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service, which rescales the raw score to a standardized T-Score with a population mean of 50 and a standard deviation of 10. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=169 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression	-3.43 T-score Standard Deviation 9.057

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants with evaluable data for DLQI.

The DLQI questionnaire designed for participants aged 17 years or more is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=35 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Change From Baseline in Dermatology Life Quality Index (DLQI)	-8.92 score on a scale Interval -10.8 to -7.1

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All participants with evaluable data for CDLQI.

The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms \& feelings, leisure, school or holidays, personal relationships, sleep, \& treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses and has a range of 0 to 30 (higher scores are indicative of greater impairment).

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=168 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)	-6.45 score on a scale Interval -7.4 to -5.5

SECONDARY outcome

Timeframe: Predose: Week 52

Population: All participants with evaluable PK data at Week 52.

Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab was evaluated at Week 52.

Outcome measures

Outcome measures
Measure	Lebrikizumab 250 mg n=138 Participants Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab	82.3 microgram per milliliter (μg/mL) Standard Deviation 39.8

Adverse Events

Lebrikizumab 250mg

Serious events: 5 serious events

Other events: 133 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lebrikizumab 250mg n=206 participants at risk Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Cardiac disorders Cardiac arrest	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Bile duct stone	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Multiple injuries	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Testicular torsion	1.0% 1/98 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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

Other adverse events
Measure	Lebrikizumab 250mg n=206 participants at risk Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52.
Blood and lymphatic system disorders Eosinophilia	3.9% 8/206 • Number of events 9 • Baseline up to Week 52 All participants who received at least one 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 Haemolytic anaemia	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Leukocytosis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Neutropenia	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Sinus arrhythmia	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Congenital, familial and genetic disorders Thyroglossal cyst	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Congenital, familial and genetic disorders Type v hyperlipidaemia	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Tinnitus	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Atopic keratoconjunctivitis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Cataract	0.49% 1/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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	1.9% 4/206 • Number of events 8 • Baseline up to Week 52 All participants who received at least one 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 Episcleritis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 irritation	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Eyelids pruritus	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Ocular hyperaemia	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Retinal detachment	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Uveitis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 discomfort	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	1.5% 3/206 • Number of events 4 • Baseline up to Week 52 All participants who received at least one 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 Angular cheilitis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Dental caries	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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	2.9% 6/206 • Number of events 9 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Gastritis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	2.4% 5/206 • Number of events 5 • Baseline up to Week 52 All participants who received at least one 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 Toothache	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Vomiting	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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	1.5% 3/206 • Number of events 5 • Baseline up to Week 52 All participants who received at least one 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	0.97% 2/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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	1.5% 3/206 • Number of events 8 • Baseline up to Week 52 All participants who received at least one 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 reaction	0.97% 2/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Malaise	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	1.9% 4/206 • Number of events 4 • Baseline up to Week 52 All participants who received at least one 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 erythema	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Drug hypersensitivity	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Food allergy	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Hypersensitivity	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Multiple allergies	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Seasonal allergy	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Cellulitis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	4.9% 10/206 • Number of events 12 • Baseline up to Week 52 All participants who received at least one 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 bacterial	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	9.2% 19/206 • Number of events 19 • Baseline up to Week 52 All participants who received at least one 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 Cystitis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Ear infection	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Eczema herpeticum	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Epididymitis	1.0% 1/98 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Herpes dermatitis	2.4% 5/206 • Number of events 11 • Baseline up to Week 52 All participants who received at least one 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 Herpes ophthalmic	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Herpes simplex	1.5% 3/206 • Number of events 7 • Baseline up to Week 52 All participants who received at least one 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 Hordeolum	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	1.5% 3/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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	9.7% 20/206 • Number of events 28 • Baseline up to Week 52 All participants who received at least one 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 Oral herpes	5.3% 11/206 • Number of events 22 • Baseline up to Week 52 All participants who received at least one 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 media	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Paronychia	1.5% 3/206 • Number of events 5 • Baseline up to Week 52 All participants who received at least one 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 Pelvic inflammatory disease	0.93% 1/108 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	1.9% 4/206 • Number of events 4 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Tinea versicolour	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Tooth abscess	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	6.3% 13/206 • Number of events 15 • Baseline up to Week 52 All participants who received at least one 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	1.5% 3/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Wound infection	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Animal bite	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Clavicle fracture	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Contusion	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Foot fracture	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Hand fracture	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Head injury	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Ligament sprain	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Muscle strain	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Nail injury	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Post procedural complication	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Procedural dizziness	0.49% 1/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Radius fracture	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Sunburn	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Thermal burn	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Wound	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	1.9% 4/206 • Number of events 5 • Baseline up to Week 52 All participants who received at least one 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 Aspartate aminotransferase increased	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Mean cell haemoglobin concentration decreased	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Platelet count increased	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 White blood cell count increased	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Decreased appetite	1.5% 3/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Gluten sensitivity	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Muscle spasms	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Myalgia	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Neck pain	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous t-cell lymphoma	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	5.8% 12/206 • Number of events 15 • Baseline up to Week 52 All participants who received at least one 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 Loss of consciousness	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Paraesthesia	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Somnolence	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Tremor	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Attention deficit hyperactivity disorder	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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	0.97% 2/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Persistent depressive disorder	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Social anxiety disorder	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Dysuria	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Dysmenorrhoea	0.93% 1/108 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Heavy menstrual bleeding	1.9% 2/108 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Menstruation irregular	1.9% 2/108 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Polymenorrhoea	0.93% 1/108 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Adenoidal hypertrophy	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Catarrh	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	3.4% 7/206 • Number of events 8 • Baseline up to Week 52 All participants who received at least one 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 Epistaxis	1.9% 4/206 • Number of events 4 • Baseline up to Week 52 All participants who received at least one 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 Nasal congestion	1.5% 3/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Oropharyngeal pain	1.9% 4/206 • Number of events 4 • Baseline up to Week 52 All participants who received at least one 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 Rhinitis allergic	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Rhinorrhoea	1.5% 3/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Tonsillar hypertrophy	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Acne	3.4% 7/206 • Number of events 7 • Baseline up to Week 52 All participants who received at least one 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 Alopecia	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Alopecia areata	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Angioedema	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Dandruff	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	12.6% 26/206 • Number of events 38 • Baseline up to Week 52 All participants who received at least one 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 Drug eruption	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Eczema	1.5% 3/206 • Number of events 3 • Baseline up to Week 52 All participants who received at least one 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 Erythema	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Hyperhidrosis	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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 Ingrowing nail	0.97% 2/206 • Number of events 2 • Baseline up to Week 52 All participants who received at least one 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	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Night sweats	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Perioral dermatitis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	2.4% 5/206 • Number of events 5 • Baseline up to Week 52 All participants who received at least one 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 erythematous	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Seborrhoeic dermatitis	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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 Skin exfoliation	0.49% 1/206 • Number of events 1 • Baseline up to Week 52 All participants who received at least one 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	2.9% 6/206 • Number of events 8 • Baseline up to Week 52 All participants who received at least one 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	1.9% 4/206 • Number of events 4 • Baseline up to Week 52 All participants who received at least one 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

Chief Medical Officer

Eli Lilly and Company

Phone: 8005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60