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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001279-34 | EudraCT Number |
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The benefit-risk profile no longer supports continuing the studies
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This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1690 600 mg | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1690 | Drug | film-coated tablets of GLPG1690 to be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | 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. | Day 1 up to 91 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Galapagos Study Director | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Arthritis Care Center | Los Angeles | California | 90045 | United States | ||
| UCLA Rheumatology |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2020 | Jan 25, 2022 |
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| Los Angeles |
| California |
| 90095 |
| United States |
| RASF Clinical Research Center | Boca Raton | Florida | 33486 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| UT Physicians Center for Autoimmunity | Houston | Texas | 77030 | United States |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50139 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | 20132 | Italy |
| Hospital Universitario Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| University Hospital Aintree | Liverpool | L9 7AL | United Kingdom |
| Royal Free Hospital | London | NW32QG | United Kingdom |
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.
| COMPLETED |
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| NOT COMPLETED |
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The open-label extension (OLE) full analysis set (FAS) was defined as all participants who had at least one intake of investigational product in the OLE study.
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| ID | Title | Description |
|---|---|---|
| BG000 | GLPG1690 600 mg | Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | 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. | Participants in the OLE-FAS were analyzed. | Posted | Count of Participants | Participants | No | Day 1 up to 91 weeks |
|
|
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Day 1 up to 91 weeks
Participants in the OLE-FAS were analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLPG1690 600 mg | Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks. | 0 | 21 | 6 | 21 | 21 | 21 |
| EG001 | 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. | 0 | 10 | 3 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Leukopenia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Skin hypertrophy | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Thyroid mass | Endocrine disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Colonic abscess | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Raynaud's phenomenon | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Discomfort | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nodule | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Disorientation | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Breast fibrosis | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Bundle branch block left | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Bundle branch block right | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Altered visual depth perception | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Anal incontinence | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Gastric antral vascular ectasia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Digital pitting scar | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Scleroderma associated digital ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Lactose intolerance | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Suspected COVID-19 | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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The benefit-risk profile no longer supports continuing the studies. Therefore, the study was terminated.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galapagos Medical Information | Galapagos NV | +32 15 342900 | medicalinfo@glpg.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 13, 2021 | Jan 25, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000621178 | GLPG1690 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|