Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis. (NCT NCT04836858)

Last Updated: 2024-06-20

Results Overview

The Investigator Global assessment (IGA) scale used was vIGA-AD\^TM (Validated Investigator Global Assessment scale for Atopic Dermatitis). The IGA rating scale was used to determine the severity of atopic dermatitis and clinical response to treatment. It reflected a participant's overall disease severity for the whole body based on a 5-point scale. The 5-point scale included: clear, almost clear, mild, moderate, and severe disease. IGA response is defined as clear or almost clear and at least a 2 point-reduction from baseline at week 16.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2024-06-20

Participant Flow

Participants took part in 18 investigative sites in 6 countries.

There was a screening period of up to 4 weeks to assess participants eligibility.

Participant milestones

Participant milestones
Measure	CMK389 10mg/kg i.v. CMK389 10 mg/kg monthly i.v. dose	CMK389 300mg s.c. CMK389 300mg monthly s.c. dose	Placebo i.v. Placebo monthly i.v. dose	Placebo s.c. Placebo monthly s.c. dose
Overall Study STARTED	38	17	8	8
Overall Study Safety Analysis Set	34	17	8	8
Overall Study COMPLETED	30	17	8	6
Overall Study NOT COMPLETED	8	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CMK389 10mg/kg i.v. CMK389 10 mg/kg monthly i.v. dose	Placebo s.c. Placebo monthly s.c. dose
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Subject/Guardian decision	3	1
Overall Study Randomized but not treated	4	0

Baseline Characteristics

A Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CMK389 10mg/kg i.v. n=34 Participants CMK389 10 mg/kg monthly i.v. dose	CMK389 300mg s.c. n=17 Participants CMK389 300mg monthly s.c. dose	Placebo i.v. n=8 Participants Placebo monthly i.v. dose	Placebo s.c. n=8 Participants Placebo monthly s.c. dose	Total n=67 Participants Total of all reporting groups
Age, Continuous	33.7 years STANDARD_DEVIATION 9.86 • n=5 Participants	34.1 years STANDARD_DEVIATION 11.35 • n=7 Participants	35.3 years STANDARD_DEVIATION 8.86 • n=5 Participants	31.9 years STANDARD_DEVIATION 8.53 • n=4 Participants	33.8 years STANDARD_DEVIATION 9.83 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	45 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	34 Participants n=5 Participants	16 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	66 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: The safety analysis set included all participants who received any study drug.

Outcome measures

Outcome measures
Measure	Placebo i.v. n=8 Participants Placebo monthly i.v. dose	Placebo s.c. n=8 Participants Placebo monthly s.c. dose	CMK389 10mg/kg i.v. n=34 Participants CMK389 10 mg/kg monthly i.v. dose	CMK389 300mg s.c. n=17 Participants CMK389 300mg monthly s.c. dose	Pooled Placebo n=16 Participants Pooled Placebo monthly i.v. and s.c. dose
Number of Participants With Investigator Global Assessment (IGA) Response	0 Participants	0 Participants	5 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.

Population: The safety analysis set included all participants who received any study drug.

Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs led to study treatment discontinuation, SAEs and SAEs led to study treatment discontinuation.

Outcome measures

Outcome measures
Measure	Placebo i.v. n=8 Participants Placebo monthly i.v. dose	Placebo s.c. n=8 Participants Placebo monthly s.c. dose	CMK389 10mg/kg i.v. n=34 Participants CMK389 10 mg/kg monthly i.v. dose	CMK389 300mg s.c. n=17 Participants CMK389 300mg monthly s.c. dose	Pooled Placebo Pooled Placebo monthly i.v. and s.c. dose
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	5 Participants	8 Participants	25 Participants	11 Participants	—
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs leading to discontinuation of study treatment	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	0 Participants	0 Participants	1 Participants	1 Participants	—
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs leading to discontinuation of study treatment	0 Participants	0 Participants	0 Participants	0 Participants	—

Adverse Events

CMK389 10 mg/kg i.v.

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

CMK389 300 mg s.c.

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo i.v.

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo s.c.

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Total

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CMK389 10 mg/kg i.v. n=34 participants at risk CMK389 10 mg/kg monthly i.v. dose	CMK389 300 mg s.c. n=17 participants at risk CMK389 300mg monthly s.c. dose	Placebo i.v. n=8 participants at risk Placebo monthly i.v. dose	Placebo s.c. n=8 participants at risk Placebo monthly s.c. dose	Pooled Placebo n=16 participants at risk Pooled Placebo monthly i.v. and s.c. dose	Total n=67 participants at risk Total
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Skin and subcutaneous tissue disorders Dermatitis atopic	2.9% 1/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.

Other adverse events

Other adverse events
Measure	CMK389 10 mg/kg i.v. n=34 participants at risk CMK389 10 mg/kg monthly i.v. dose	CMK389 300 mg s.c. n=17 participants at risk CMK389 300mg monthly s.c. dose	Placebo i.v. n=8 participants at risk Placebo monthly i.v. dose	Placebo s.c. n=8 participants at risk Placebo monthly s.c. dose	Pooled Placebo n=16 participants at risk Pooled Placebo monthly i.v. and s.c. dose	Total n=67 participants at risk Total
Blood and lymphatic system disorders Anaemia	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Cardiac disorders Sinus bradycardia	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Ear and labyrinth disorders Vertigo	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Eye disorders Eyelid oedema	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Eye disorders Visual impairment	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Gastrointestinal disorders Diarrhoea	8.8% 3/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	11.8% 2/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	7.5% 5/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Gastrointestinal disorders Nausea	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
General disorders Fatigue	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
General disorders Injection site reaction	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Infections and infestations Bacteriuria	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Infections and infestations COVID-19	29.4% 10/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	29.4% 5/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	37.5% 3/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	25.0% 4/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	28.4% 19/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Infections and infestations Nasopharyngitis	20.6% 7/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	23.5% 4/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 2/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	19.4% 13/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Infections and infestations Otitis externa	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Infections and infestations Rhinitis	2.9% 1/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Infections and infestations Upper respiratory tract infection	2.9% 1/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Alanine aminotransferase increased	5.9% 2/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Aspartate aminotransferase increased	5.9% 2/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Blood creatine increased	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Blood creatine phosphokinase increased	5.9% 2/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	4.5% 3/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Blood ketone body increased	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Glucose urine	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Lymphocyte count decreased	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Urinary sediment present	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Investigations Urine analysis abnormal	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 2/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Nervous system disorders Dizziness	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Nervous system disorders Headache	8.8% 3/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	7.5% 5/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Nervous system disorders Migraine	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	25.0% 2/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 2/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Renal and urinary disorders Hypertonic bladder	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	12.5% 1/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	6.2% 1/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Skin and subcutaneous tissue disorders Dermatitis atopic	5.9% 2/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	11.8% 2/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	50.0% 4/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	25.0% 4/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	11.9% 8/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	5.9% 1/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	1.5% 1/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.
Vascular disorders Hypertension	0.00% 0/34 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	11.8% 2/17 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/8 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	0.00% 0/16 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.	3.0% 2/67 • AEs were reported from first dose until the end of the 12 weeks follow up period, up to a max. duration of approx. 197 days. For women of child-bearing potential, pregnancies were reported (if occurred) for up to approx. 268 days after first dose.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
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