A clinical study to test how effective and safe GLPG1690 is for patients with Systemic Sclerosis
- Conditions
- Systemic sclerosisMedDRA version: 20.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-001817-33-BE
- Lead Sponsor
- Galapagos NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
- Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the IEC/IRB, prior to any screening evaluations.
- Male and female subjects =18 years at the time of consent who meet the American College of Rheumatology (ACR)/EULAR 2013 diagnostic criteria (Van den Hoogen F. et al., 2013) for systemic sclerosis with diffuse cutaneous involvement (according to LeRoy’s criteria) and =5 years since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon.
- mRSS >10 at screening.
- Active disease at screening, as defined by: Worsening of skin thickening (=2 mRSS points) as assessed by mRSS measured at screening versus a previous mRSS assessment made within 6 months prior to screening, or new areas of skin involvement within 6 months prior to screening as documented by physician note, or new-onset systemic sclerosis with symptoms or signs other than Raynaud’s phenomenon within 2 years prior to screening, or =1 tendon friction rub (palpated in the finger flexors or extensors, wrist flexors or extensors, olecranon bursa, shoulders, knees, anterior or posterior ankles with active motion).
- Subject must be able and willing to comply with restrictions on prior and concomitant medication as described in the protocol
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
- Female subjects of childbearing potential or male subjects with female partners of childbearing potential must be willing to comply with the contraceptive methods described in the protocol prior to the first dose of the IMP, during the clinical study, and for at least 90 days after the last dose of the IMP for male subjects and 30 days after the last dose of the IMP for female subjects.
- A body mass index (BMI) between 18–35 kg/m2, inclusive, at screening.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered non-clinically significant in the opinion of the investigator.
This list only contains the key inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
- Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to any drug as determined by the investigator, such as anaphylaxis requiring hospitalization.
- Breastfeeding female or subject intending to become pregnant or breastfeed.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired).
- Positive serology for hepatitis B (surface antigen) or C (antibody), or any history of hepatitis from any cause. For hepatitis A, a history of infection within 12 weeks prior to screening. Positive serology for HIV-1 and HIV-2 (antibodies).
- History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, prostate cancer medically managed through active surveillance or watchful waiting, and squamous cell carcinoma of the skin if fully resected).
- Clinically significant abnormalities detected on ECG at screening of either rhythm or conduction, QTcF >450 ms, or a known long QT syndrome.
- Unstable cardiovascular, pulmonary, or other disease (other than systemic sclerosis-related) within 6 months prior to the baseline visit (e.g. coronary heart disease, heart failure, stroke).
- Severe pulmonary disease with FVC =45% of predicted within 6 months prior to the baseline visit.
- Chronic or ongoing active infectious disease, including tuberculosis (requiring hospitalization or systemic treatment within 4 weeks prior to the baseline visit).
- Abnormal liver function test (LFT) at screening, defined as aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT), and/or bilirubin, and/or alkaline phosphatase >2x upper limit of normal (ULN). Retesting is allowed once.
This list only contains the key exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of GLPG1690 as evaluated by mRSS compared to placebo over 24 weeks for the treatment of subjects with systemic sclerosis;Secondary Objective: To evaluate the safety and tolerability of GLPG1690 compared to placebo over 24 weeks in the treatment of subjects with systemic sclerosis;Primary end point(s): Change from baseline in mRSS over 24 weeks;Timepoint(s) of evaluation of this end point: Various timepoints during the trial as specified in the protocol
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Incidence of TEAEs, serious adverse events (SAEs), AEs, and tolerability of GLPG1690 over 24 weeks;Timepoint(s) of evaluation of this end point: Various timepoints during the trial as specified in the protocol