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

NCT ID: NCT03976648

Last Updated: 2022-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2021-04-13

Brief Summary

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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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Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

GLPG1690

Intervention Type DRUG

film-coated tablets of GLPG1690 to be administered orally

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.

Group Type EXPERIMENTAL

GLPG1690

Intervention Type DRUG

film-coated tablets of GLPG1690 to be administered orally

Interventions

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GLPG1690

film-coated tablets of GLPG1690 to be administered orally

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galapagos NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Galapagos Study Director

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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Pacific Arthritis Care Center

Los Angeles, California, United States

Site Status

UCLA Rheumatology

Los Angeles, California, United States

Site Status

RASF Clinical Research Center

Boca Raton, Florida, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status

UT Physicians Center for Autoimmunity

Houston, Texas, United States

Site Status

UZ Gent

Ghent, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status

Ospedale San Raffaele S.r.l. - PPDS

Milan, , Italy

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

University Hospital Aintree

Liverpool, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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United States Belgium Italy Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-001279-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG1690-CL-206

Identifier Type: -

Identifier Source: org_study_id

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