A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
Sponsor
Galapagos NV (Industry)
Overall Status
Terminated
CT.gov ID
NCT03976648
Collaborator
(none)
31
14
2
20.9
2.2
0.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
31 participants
Allocation:
N/A
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis
Actual Study Start Date
:
Jul 18, 2019
Actual Primary Completion Date
:
Apr 13, 2021
Actual Study Completion Date
:
Apr 13, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: GLPG1690
film-coated tablets of GLPG1690 to be administered orally
|
| Experimental: 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. |
Drug: GLPG1690
film-coated tablets of GLPG1690 to be administered orally
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs [Day 1 up to 91 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Male or female participants who completed the 24-week treatment period of Study GLPG1690-CL-204 and who according to the investigator's judgment may benefit from long-term treatment with GLPG1690.
Exclusion Criteria:
- Any condition or circumstances that, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pacific Arthritis Care Center | Los Angeles | California | United States | 90045 |
| 2 | UCLA Rheumatology | Los Angeles | California | United States | 90095 |
| 3 | RASF Clinical Research Center | Boca Raton | Florida | United States | 33486 |
| 4 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 5 | Metroplex Clinical Research Center | Dallas | Texas | United States | 75231 |
| 6 | UT Physicians Center for Autoimmunity | Houston | Texas | United States | 77030 |
| 7 | UZ Gent | Gent | Belgium | 9000 | |
| 8 | UZ Leuven | Leuven | Belgium | 3000 | |
| 9 | Azienda Ospedaliero Universitaria Careggi | Firenze | Italy | 50139 | |
| 10 | Ospedale San Raffaele S.r.l. - PPDS | Milano | Italy | 20132 | |
| 11 | Hospital Universitario Vall d'Hebron | Barcelona | Spain | 8035 | |
| 12 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 13 | University Hospital Aintree | Liverpool | United Kingdom | L9 7AL | |
| 14 | Royal Free Hospital | London | United Kingdom | NW32QG |
Sponsors and Collaborators
- Galapagos NV
Investigators
- Study Director: Galapagos Study Director, Galapagos NV
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT03976648
Other Study ID Numbers:
- GLPG1690-CL-206
- 2019-001279-34
First Posted:
Jun 6, 2019
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | GLPG1690 600 mg | Placebo |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 21 | 10 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 21 | 10 |
Baseline Characteristics
| Arm/Group Title | GLPG1690 600 mg | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks. | 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 of all reporting groups |
| Overall Participants | 21 | 10 | 31 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
50.4
(13.58)
|
49.4
(18.57)
|
50.1
(15.06)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
71.4%
|
6
60%
|
21
67.7%
|
| Male |
6
28.6%
|
4
40%
|
10
32.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
4.8%
|
0
0%
|
1
3.2%
|
| Not Hispanic or Latino |
20
95.2%
|
10
100%
|
30
96.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
10%
|
1
3.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
21
100%
|
9
90%
|
30
96.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
|---|---|
| Description | 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. |
| Time Frame | Day 1 up to 91 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the OLE-FAS were analyzed. |
| Arm/Group Title | GLPG1690 600 mg | Placebo |
|---|---|---|
| Arm/Group Description | Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks. | 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. |
| Measure Participants | 21 | 10 |
| TEAEs |
21
100%
|
10
100%
|
| Serious TEAEs |
6
28.6%
|
3
30%
|
Adverse Events
| Time Frame | Day 1 up to 91 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Participants in the OLE-FAS were analyzed. | |||
| Arm/Group Title | GLPG1690 600 mg | Placebo | ||
| Arm/Group Description | Participants who received GLPG1690 600 mg in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks. | 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. | ||
All Cause Mortality |
||||
| GLPG1690 600 mg | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | 0/10 (0%) | ||
Serious Adverse Events |
||||
| GLPG1690 600 mg | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/21 (28.6%) | 3/10 (30%) | ||
| Cardiac disorders | ||||
| Atrial tachycardia | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 |
| Endocrine disorders | ||||
| Thyroid mass | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diverticulum intestinal | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 |
| Rectal prolapse | 0/21 (0%) | 0 | 1/10 (10%) | 2 |
| Infections and infestations | ||||
| Colonic abscess | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 |
| Device related infection | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 |
| Pharyngitis | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 |
| Sepsis | 2/21 (9.5%) | 3 | 0/10 (0%) | 0 |
| Urinary tract infection | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Female genital tract fistula | 1/21 (4.8%) | 1 | 0/10 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Interstitial lung disease | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 |
| Pneumothorax | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Leukopenia | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Skin hypertrophy | 1/21 (4.8%) | 2 | 0/10 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| GLPG1690 600 mg | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/21 (100%) | 10/10 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Leukopenia | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Normocytic anaemia | 0/21 (0%) | 0 | 2/10 (20%) | 2 |
| Cardiac disorders | ||||
| Bundle branch block left | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Atrial fibrillation | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Palpitations | 4/21 (19%) | 4 | 0/10 (0%) | 0 |
| Bundle branch block right | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Pericarditis | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Ventricular extrasystoles | 2/21 (9.5%) | 3 | 0/10 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Hydrocele | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Eye disorders | ||||
| Altered visual depth perception | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Blepharitis | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 3/21 (14.3%) | 3 | 0/10 (0%) | 0 |
| Abdominal distension | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Anal incontinence | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Aphthous ulcer | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Constipation | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Diarrhoea | 8/21 (38.1%) | 13 | 4/10 (40%) | 7 |
| Dysphagia | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Dyspepsia | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Eructation | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Gastric antral vascular ectasia | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Gastrooesophageal reflux disease | 2/21 (9.5%) | 3 | 1/10 (10%) | 1 |
| Oesophagitis | 2/21 (9.5%) | 2 | 1/10 (10%) | 1 |
| Nausea | 4/21 (19%) | 6 | 1/10 (10%) | 1 |
| General disorders | ||||
| Discomfort | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Nodule | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Fatigue | 2/21 (9.5%) | 3 | 0/10 (0%) | 0 |
| Pyrexia | 1/21 (4.8%) | 3 | 1/10 (10%) | 1 |
| Peripheral swelling | 4/21 (19%) | 5 | 1/10 (10%) | 1 |
| Infections and infestations | ||||
| Bronchitis | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| COVID-19 | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Conjunctivitis | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Cellulitis | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Infected skin ulcer | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Influenza | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Oral herpes | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Nasopharyngitis | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Otitis media | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Paronychia | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Rhinitis | 2/21 (9.5%) | 2 | 1/10 (10%) | 1 |
| Pharyngitis | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Suspected COVID-19 | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Upper respiratory tract infection | 5/21 (23.8%) | 7 | 1/10 (10%) | 1 |
| Urinary tract infection | 6/21 (28.6%) | 11 | 0/10 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Procedural pain | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Investigations | ||||
| Alanine aminotransferase increased | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Weight increased | 2/21 (9.5%) | 3 | 0/10 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Lactose intolerance | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Dyslipidaemia | 2/21 (9.5%) | 2 | 1/10 (10%) | 1 |
| Vitamin D deficiency | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Decreased appetite | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 4/21 (19%) | 7 | 0/10 (0%) | 0 |
| Back pain | 3/21 (14.3%) | 4 | 0/10 (0%) | 0 |
| Muscle spasms | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Bursitis | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Musculoskeletal chest pain | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Muscular weakness | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Musculoskeletal stiffness | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Myalgia | 1/21 (4.8%) | 1 | 1/10 (10%) | 2 |
| Rotator cuff syndrome | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Pain in extremity | 1/21 (4.8%) | 1 | 1/10 (10%) | 2 |
| Tendonitis | 2/21 (9.5%) | 4 | 0/10 (0%) | 0 |
| Nervous system disorders | ||||
| Dizziness | 3/21 (14.3%) | 3 | 2/10 (20%) | 3 |
| Headache | 6/21 (28.6%) | 6 | 2/10 (20%) | 3 |
| Psychiatric disorders | ||||
| Disorientation | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Reproductive system and breast disorders | ||||
| Breast fibrosis | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Vaginal haemorrhage | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Vaginal discharge | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 7/21 (33.3%) | 9 | 1/10 (10%) | 1 |
| Oropharyngeal pain | 2/21 (9.5%) | 2 | 0/10 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Digital pitting scar | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Dermatitis psoriasiform | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Hyperhidrosis | 2/21 (9.5%) | 2 | 1/10 (10%) | 1 |
| Hair growth abnormal | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Night sweats | 1/21 (4.8%) | 1 | 1/10 (10%) | 1 |
| Perioral dermatitis | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Rash macular | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Scleroderma associated digital ulcer | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Skin ulcer | 6/21 (28.6%) | 14 | 1/10 (10%) | 4 |
| Skin lesion | 5/21 (23.8%) | 6 | 1/10 (10%) | 1 |
| Urticaria | 0/21 (0%) | 0 | 1/10 (10%) | 2 |
| Telangiectasia | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Vascular disorders | ||||
| Hot flush | 0/21 (0%) | 0 | 1/10 (10%) | 1 |
| Raynaud's phenomenon | 3/21 (14.3%) | 5 | 0/10 (0%) | 0 |
Limitations/Caveats
The benefit-risk profile no longer supports continuing the studies. Therefore, the study was terminated.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Galapagos Medical Information |
|---|---|
| Organization | Galapagos NV |
| Phone | +32 15 342900 |
| medicalinfo@glpg.com |
Responsible Party:
Galapagos NV
ClinicalTrials.gov Identifier:
NCT03976648
Other Study ID Numbers:
- GLPG1690-CL-206
- 2019-001279-34
First Posted:
Jun 6, 2019
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022