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A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis (NOVESA)

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ClinicalTrials.gov Identifier: NCT03798366
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

The main purpose of the study is to see if GLPG1690 helps (together with the standard of care treatment) in the treatment of the skin and other areas affected by systemic sclerosis.

Another aim is to find out how safe/well tolerated GLPG1690 will be and whether there are any side effects. The study will also look at other things, including whether the study drug affects disease progression and also if it changes any aspect of the quality of life.


Condition or disease Intervention/treatment Phase
Scleroderma Drug: GLPG1690 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: GLPG1690 Drug: GLPG1690
film-coated tablets of GLPG1690 for oral use

Placebo Comparator: Placebo Drug: Placebo
film-coated tablets of matching placebo for oral use




Primary Outcome Measures :
  1. Change from baseline in modified Rodnan skin score (mRSS) over 24 weeks [ Time Frame: At screening and Week 24 ]
    To evaluate the efficacy of GLPG1690 as evaluated by mRSS compared to placebo over 24 weeks for the treatment of subjects with systemic sclerosis. The 17-site mRSS will be used, with each body site assessed for skin thickness on a scale of 0 (uninvolved) to 3 (severe thickening) with a maximum score of 51.


Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) over 24 weeks as assessed by CTCAE version 5.0. [ Time Frame: From screening until Week 24 ]
    To evaluate the safety and tolerability of GLPG1690 compared to placebo over 24 weeks in the treatment of subjects with systemic sclerosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (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 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 investigational medicinal product (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.

Exclusion Criteria:

  • 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, QT interval corrected for heart rate using Fridericia's formula (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 forced vital capacity (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798366


Contacts
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Contact: Galapagos Medical Information +3215342900 medicalinfo@glpg.com

Locations
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United States, California
Pacific Arthritis Care Center Recruiting
Los Angeles, California, United States, 90045
United States, Florida
RASF Clinical Research Center Recruiting
Boca Raton, Florida, United States, 33486
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
United Kingdom
University Hospital Aintree Recruiting
Liverpool, United Kingdom, L9 7AL
Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Dick de Vries, MD Galapagos NV

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03798366     History of Changes
Other Study ID Numbers: GLPG1690-CL-204
2018-001817-33 ( EudraCT Number )
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Skin Diseases