Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02738801
• Date of registration: 11/04/2016
• Prospective Registration: No
• Primary sponsor: Galapagos NV
• Public title: Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific title: Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter, Exploratory Phase IIa Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 Administered for 12 Weeks in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
• Date of first enrolment: March 2016
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02738801
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Italy, Ukraine, United Kingdom

Contacts

• Name: Ann Fieuw, MD
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects able and willing to sign the Institutional Review Board (IRB)/Independent
Ethics Committee (IEC) approved Informed Consent Form (ICF)

2. Male or female subjects of non-child-bearing potential aged = 40 years

3. Subjects with a chest HRCT performed within 12 months prior to screening

4. Subjects with IPF diagnosed by a multidisciplinary team

5. Subjects with: a. forced vital capacity (FVC) =50% predicted of normal AND b.
Diffusing capacity for the lungs for carbon monoxide (DLCO) = 30% predicted of normal
corrected for hemoglobin

6. Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli
index) ratio = 0.70 (based on pre-bronchodilator spirometry

7. Subjects on stable supportive care

8. Subjects in stable condition

Exclusion Criteria:

1. Subjects with know hypersensitivity to any of the study drug ingredients

2. Subjects with a history of or current immunosuppressive condition

3. Subjects with a history of malignancy within the past 5 years

4. Subjects with clinically significant abnormalities on ECG

5. Subjects with acute IPF exacerbation within 6 weeks prior to screening

6. Subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks
prior to screening

7. Smoking within 3 months pre-screening

8. Interstitial lung disease

9. History of lung volume reduction surgery or lung transplant

10. Unstable cardiac or pulmonary disease other than IPF within 6 months prior to
screening

11. Subjects with abnormal liver function

12. Subjects with abnormal renal function



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Placebo QD

Drug: GLPG1690 600 mg QD

Primary Outcome(s)

Mean Area Under the Plasma Concentration-Time Curve (AUC[t]; µg.h/mL) of GLPG1690 [Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28]

Median Time to Occurrence of GLPG1690 Cmax (Tmax; Hours [h]) [Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28]

Mean GLPG1690 Plasma Concentration Observed at Predose (Ctrough; µg/mL) [Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28]

Mean Maximum Observed Plasma Concentration (Cmax; Micrograms Per Milliliter [µg/mL]) of GLPG1690 [Time Frame: Baseline, predose on Days 7, 14, 28, 56, 84, and 98 (or at early discontinuation), and at 1.5, 4, and 6 hours postdose on Day 28]

Number of Patients With Treatment-Emergent Adverse Events (AEs) [Time Frame: From screening up to Day 98]

Mean Peak Area Ratio of LPA C18:2 Species in Bronchoalveolar Lavage Fluid (BALF) [Time Frame: Baseline (Day -1) and Day 84]

Mean Peak Area Ratio of Lysophosphatidic Acid (LPA) C18:2 Species in Blood [Time Frame: Baseline (Day -1), predose and 1.5 and 6 hours postdose on Day 28, predose on Day 84, and Day 98 (or early discontinuation)]

Secondary ID(s)

2015-004157-41

GLPG1690-CL-202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02738801