NCT03976648

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2019

Geographic Reach
5 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 15, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

June 4, 2019

Results QC Date

February 16, 2022

Last Update Submit

March 16, 2022

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

    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.

    Day 1 up to 91 weeks

Study Arms (2)

GLPG1690 600 mg

EXPERIMENTAL

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

Placebo

EXPERIMENTAL

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

Interventions

GLPG1690DRUG

film-coated tablets of GLPG1690 to be administered orally

GLPG1690 600 mgPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Pacific Arthritis Care Center

Los Angeles, California, 90045, United States

Location

UCLA Rheumatology

Los Angeles, California, 90095, United States

Location

RASF Clinical Research Center

Boca Raton, Florida, 33486, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

UT Physicians Center for Autoimmunity

Houston, Texas, 77030, United States

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50139, Italy

Location

Ospedale San Raffaele S.r.l. - PPDS

Milan, 20132, Italy

Location

Hospital Universitario Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

Location

Royal Free Hospital

London, NW32QG, United Kingdom

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

GLPG1690

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Limitations and Caveats

The benefit-risk profile no longer supports continuing the studies. Therefore, the study was terminated.

Results Point of Contact

Title
Galapagos Medical Information
Organization
Galapagos NV
medicalinfo@glpg.com
+32 15 342900

Study Officials

  • Galapagos Study Director

    Galapagos NV

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 6, 2019

Study Start

July 18, 2019

Primary Completion

April 13, 2021

Study Completion

April 13, 2021

Last Updated

March 29, 2022

Results First Posted

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(6)GB(2)IT(2)ES(2)BE(2)