Trial Outcomes & Findings for A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis (NCT NCT03976648)
NCT ID: NCT03976648
Last Updated: 2022-03-29
Results Overview
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. Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Day 1 up to 91 weeks
Results posted on
2022-03-29
Participant Flow
Participants were enrolled at study sites in Belgium, Italy, Spain, the United Kingdom, and the United States. The first participant was screened on 18 Jul 2019. The last study visit occurred on 13 Apr 2021. The treatment duration was planned for 104 weeks but the study was terminated at 91 weeks.
A total of 31 participants who completed 24-week double-blind treatment in the GLPG1690-CL-204 (NCT03798366) study were rolled over and randomized in this study.
Participant milestones
| Measure |
GLPG1690 600 mg
Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
Placebo
Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
10
|
Reasons for withdrawal
| Measure |
GLPG1690 600 mg
Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
Placebo
Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Study terminated by sponsor
|
21
|
8
|
Baseline Characteristics
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Baseline characteristics by cohort
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
Placebo
n=10 Participants
Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 13.58 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 18.57 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 15.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 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
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=7 Participants
|
0 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
|
9 Participants
n=7 Participants
|
30 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
|
PRIMARY outcome
Timeframe: Day 1 up to 91 weeksPopulation: Participants in the OLE-FAS were analyzed.
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. Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.
Outcome measures
| Measure |
GLPG1690 600 mg
n=21 Participants
Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
Placebo
n=10 Participants
Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
21 Participants
|
10 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
6 Participants
|
3 Participants
|
Adverse Events
GLPG1690 600 mg
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GLPG1690 600 mg
n=21 participants at risk
Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
Placebo
n=10 participants at risk
Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial tachycardia
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
4.8%
1/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Leukopenia
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
4.8%
1/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Endocrine disorders
Thyroid mass
|
4.8%
1/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Colonic abscess
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Device related infection
|
4.8%
1/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Pharyngitis
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Sepsis
|
9.5%
2/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
Other adverse events
| Measure |
GLPG1690 600 mg
n=21 participants at risk
Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
Placebo
n=10 participants at risk
Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
|
|---|---|---|
|
Vascular disorders
Hot flush
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Vascular disorders
Raynaud's phenomenon
|
14.3%
3/21 • Number of events 5 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
General disorders
Discomfort
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
General disorders
Nodule
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
General disorders
Fatigue
|
9.5%
2/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
General disorders
Peripheral swelling
|
19.0%
4/21 • Number of events 5 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Investigations
Weight increased
|
9.5%
2/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Cardiac disorders
Bundle branch block left
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Cardiac disorders
Palpitations
|
19.0%
4/21 • Number of events 4 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Cardiac disorders
Ventricular extrasystoles
|
9.5%
2/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
20.0%
2/10 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
7/21 • Number of events 9 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
20.0%
2/10 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Nervous system disorders
Headache
|
28.6%
6/21 • Number of events 6 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
20.0%
2/10 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Eye disorders
Altered visual depth perception
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Eye disorders
Blepharitis
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
3/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.1%
8/21 • Number of events 13 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
40.0%
4/10 • Number of events 7 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Dysphagia
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.5%
2/21 • Number of events 3 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Oesophagitis
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Digital pitting scar
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Scleroderma associated digital ulcer
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
28.6%
6/21 • Number of events 14 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 4 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
23.8%
5/21 • Number of events 6 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.0%
4/21 • Number of events 7 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
3/21 • Number of events 4 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
9.5%
2/21 • Number of events 4 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
COVID-19
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Conjunctivitis
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Cellulitis
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Infected skin ulcer
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Influenza
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Otitis media
|
4.8%
1/21 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Paronychia
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Rhinitis
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Pharyngitis
|
9.5%
2/21 • Number of events 2 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/21 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.8%
5/21 • Number of events 7 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Infections and infestations
Urinary tract infection
|
28.6%
6/21 • Number of events 11 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
0.00%
0/10 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • Number of events 6 • Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
|
10.0%
1/10 • Number of events 1 • Day 1 up to 91 weeks
Participants in the OLE-FAS 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