Trial Outcomes & Findings for A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis (NCT NCT03798366)
NCT ID: NCT03798366
Last Updated: 2021-05-04
Results Overview
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Baseline, Week 4
Results posted on
2021-05-04
Participant Flow
Participants were enrolled at study sites in Belgium, the United States, United Kingdom, Spain, and Italy. The first participant was screened on 14 Jan 2019. The last study visit occurred on 22 Jun 2020.
A total of 40 participants were screened, of whom 33 participants were randomized and treated.
Participant milestones
| Measure |
GLPG1690 600 mg
Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.
|
Placebo
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
12
|
|
Overall Study
COMPLETED
|
21
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
GLPG1690 600 mg
Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks.
|
Placebo
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis
Baseline characteristics by cohort
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 Participants
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 13.58 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 17.99 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 15.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Modified Rodnan Skin Score (mRSS)
|
27.0 units on a scale
STANDARD_DEVIATION 8.84 • n=5 Participants
|
22.5 units on a scale
STANDARD_DEVIATION 6.24 • n=7 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 8.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: Participants in the FAS were analyzed.
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
Outcome measures
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 Participants
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in mRSS at Week 4
|
-2.2 units on a scale
Standard Error 0.85
|
-1.6 units on a scale
Standard Error 1.04
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Participants in the FAS were analyzed.
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
Outcome measures
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 Participants
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in mRSS at Week 8
|
-3.2 units on a scale
Standard Error 0.85
|
-2.5 units on a scale
Standard Error 1.07
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS were analyzed.
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
Outcome measures
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 Participants
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in mRSS at Week 16
|
-6.8 units on a scale
Standard Error 0.85
|
-4.8 units on a scale
Standard Error 1.12
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Participants in the FAS were analyzed.
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
Outcome measures
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 Participants
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in mRSS at Week 24
|
-8.9 units on a scale
Standard Error 0.87
|
-6.0 units on a scale
Standard Error 1.11
|
SECONDARY outcome
Timeframe: Baseline up to end of the study (36 weeks)Population: Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.
An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant.
Outcome measures
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 Participants
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
20 Participants
|
11 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
2 Participants
|
1 Participants
|
Adverse Events
GLPG1690 600 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GLPG1690 600 mg
n=21 participants at risk
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 participants at risk
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Device related infection
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Pharyngitis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
Other adverse events
| Measure |
GLPG1690 600 mg
n=21 participants at risk
Participants received GLPG1690 600 mg, orally once daily for 24 weeks.
|
Placebo
n=12 participants at risk
Participants received GLPG1690 matching placebo, orally once daily for 24 weeks.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
16.7%
2/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Rhinitis
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
3/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Cellulitis
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Influenza
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Pharyngitis
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Conjunctivitis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Gastroenteritis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Gastroenteritis viral
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Herpes zoster
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Hordeolum
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Otitis media
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
7/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
16.7%
2/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Oesophagitis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Gingival recession
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Nervous system disorders
Headache
|
23.8%
5/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
16.7%
2/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Nervous system disorders
Dyskinesia
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Nervous system disorders
Memory impairment
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Nervous system disorders
Migraine
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
19.0%
4/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Digital pitting scar
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
3/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
General disorders
Peripheral swelling
|
14.3%
3/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
General disorders
Discomfort
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
General disorders
Malaise
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
General disorders
Pyrexia
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Cardiac disorders
Palpitations
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Investigations
Weight increased
|
9.5%
2/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
16.7%
2/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Psychiatric disorders
Anger
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Renal and urinary disorders
Pollakiuria
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Vascular disorders
Hot flush
|
0.00%
0/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
8.3%
1/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Vascular disorders
Raynaud's phenomenon
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Ear and labyrinth disorders
Vertigo
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
|
Eye disorders
Vision blurred
|
4.8%
1/21 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
0.00%
0/12 • Baseline up to end of the study (36 weeks)
Participants in the safety analysis set were analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER