A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis

Study Purpose

This study is the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study is to see how GLPG1690 is tolerated in participants with systemic sclerosis and whether there are any side effects in a long-term treatment period.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female subjects 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 subject unlikely or unable to complete the study or comply with study procedures and requirements.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03976648
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Galapagos NV
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dick de Vries, MD
Principal Investigator Affiliation Galapagos NV
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sclerosis, Systemic
Arms & Interventions

Arms

Experimental: GLPG1690

Interventions

Drug: - GLPG1690

film-coated tablets of GLPG1690 for oral use

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

RASF Clinical Research Center, Boca Raton, Florida

Status

Recruiting

Address

RASF Clinical Research Center

Boca Raton, Florida, 33486

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Metroplex Clinical Research Center, Dallas, Texas

Status

Recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

International Sites

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Hospital Universitario Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Vall d'Hebron

Barcelona, , 8035

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

University Hospital Aintree, Liverpool, United Kingdom

Status

Recruiting

Address

University Hospital Aintree

Liverpool, , L9 7AL

Royal Free Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Free Hospital

London, , NW32QG