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Clinical Trials/NCT04578548
NCT04578548
Terminated
Phase 2

An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, Followed by an Open-label Extension Period of 52 Weeks in Participants With Autosomal Dominant Polycystic Kidney Disease

Galapagos NV20 sites in 7 countries66 target enrollmentNovember 10, 2020

Overview

Phase
Phase 2
Intervention
Placebo
Conditions
Autosomal Dominant Polycystic Kidney Disease
Sponsor
Galapagos NV
Enrollment
66
Locations
20
Primary Endpoint
DB Period: Mean Percent Change From MRI Baseline in htTKV
Status
Terminated
Last Updated
last year

Overview

Brief Summary

This is an exploratory, randomized, double-blind, placebo-controlled, parallel group, multicenter, proof of concept study (Phase 2a), evaluating orally administered GLPG2737 for a double-blind (DB) treatment period of 52 weeks and 4 weeks of follow up as well as an open-label extension (OLE) treatment period of 52 weeks and 4 weeks of follow-up, in participants with rapidly progressing ADPKD.

Registry
clinicaltrials.gov
Start Date
November 10, 2020
End Date
April 4, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Placebo During DB + GLPG2737 During OLE

Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period. Eligible participants were rolled over to an OLE period to receive 150 mg GLPG2737 orally once daily for 52 weeks.

Intervention: Placebo

GLPG2737 During DB + During OLE

Participants received 150 milligrams (mg) GLPG2737 capsules orally once daily for 52 weeks in the double-blind (DB) treatment period. Eligible participants were rolled over to an open-label extension (OLE) period to receive 150 mg GLPG2737 orally once daily for 52 weeks.

Intervention: GLPG2737

Placebo During DB + GLPG2737 During OLE

Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period. Eligible participants were rolled over to an OLE period to receive 150 mg GLPG2737 orally once daily for 52 weeks.

Intervention: GLPG2737

Outcomes

Primary Outcomes

DB Period: Mean Percent Change From MRI Baseline in htTKV

Time Frame: MRI Baseline up to Week 52

htTKV is used in participants with ADPKD disease to predict the onset of renal insufficiency. htTKV was calculated using TKV (in mL) obtained from MRI divided by height (in m). MRI Baseline: For MRI assessments, all non-missing values before the first study drug administration in the study +14 days (included) was considered as the primary baseline definition. Results were derived by mean of the individual slopes (i.e. using all MRI performed between baseline and Week 52).

DB Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

Time Frame: From first dose to Week 56

An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug, whether or not considered related to it. A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results a congenital anomaly/birth defect or other medically important event. A TEAE was defined as an AE observed after starting administration of the study drug until 30 days after last DB dose or 1 day before OLE dose, whichever occurred first.

Secondary Outcomes

  • DB Period: Maximum Observed Plasma Concentration (Cmax) of GLPG2737 and Its Metabolite(Predose (within 30 minutes prior to dosing), 1, 1.5, 2, 3, 4, 5, 6, 7 hours post dose through Week 52)
  • DB Period: Mean Change From Baseline in eGFR(Baseline up to Week 52)
  • DB Period: Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of GLPG2737 and Its Metabolite(Predose (within 30 minutes prior to dosing), 1, 1.5, 2, 3, 4, 5, 6, 7 hours post dose through Week 52)

Study Sites (20)

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