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Trial record 2 of 6 for:    glpg1205

A Clinical Study to Test How Effective and Safe GLPG1205 is for Patients With Idiopathic Pulmonary Fibrosis (IPF) (PINTA)

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ClinicalTrials.gov Identifier: NCT03725852
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:
This is a randomized, double-blind, parallel group, placebo-controlled, multicenter, exploratory Phase II study including subjects with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 of top of local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib or pirfenidone).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: GLPG1205 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : April 25, 2020
Estimated Study Completion Date : May 16, 2020


Arm Intervention/treatment
Experimental: GLPG1205 dose A
GLPG1205 will be taken as 2 capsules, once daily (q.d.), administered for 26 weeks on top of local standard of care.
Drug: GLPG1205
GLPG1205 will be provided as an oral hard gelatin capsule.

Placebo Comparator: Placebo
Matching placebo once daily (q.d.) administered for 26 weeks on top of local standard of care.
Drug: Placebo
matching placebo will be provided as an oral hard gelatin capsule.




Primary Outcome Measures :
  1. Change from baseline in forced vital capacity (FVC) (mL) over 26 weeks compared to placebo. [ Time Frame: From Day 1 to Week 26 ]
    To evaluate the efficacy of GLPG1205 treatment in subjects with IPF on pulmonary function as evaluated by FVC compared to placebo over 26 weeks.


Secondary Outcome Measures :
  1. The number of incidents of Treatment-Emergent Adverse Events (TEAEs), Unlisted (Unexpected) Adverse Events, Serious Adverse Events (SAEs), and discontinuations due to Adverse Events (AEs). [ Time Frame: From Day 1 to Week 26 ]
    To evaluate the safety and tolerability of GLPG1205 treatment compared to placebo over 26 weeks.

  2. Time to any of major events (whichever occurs first) defined as below: [ Time Frame: From Day 1 through study completion up to Week 30 ]

    To evaluate the impact of GLPG1205 treatment compared to placebo on time to any major events (whichever occurs first) defined as:

    • Respiratory-related mortality
    • Hospitalization (all-cause and respiratory related)
    • Need for placement on a lung transplant list

  3. Change from baseline in functional exercise capacity, assessed by the six-minute walk test (6MWT) at Week 26. [ Time Frame: From Day 1 to Week 26 ]
    To evaluate the changes from baseline in functional exercise capacity measured by the 6MWT, in IPF subjects treated with GLPG1205 compared to placebo at Week 26.

  4. Change from baseline until 26 weeks in quality of life measures, assessed by the St.George's Respiratory Questionnaire (SGRQ) total score and domains and proportion of SGRQ responders. [ Time Frame: From Day 1 to Week 26 ]
    To evaluate the changes in quality of life measures in IPF subjects treated with GLPG1205 compared to placebo over 26 weeks.

  5. Concentrations of GLPG1205, nintedanib and pirfenidone. [ Time Frame: From Day 1 to Week 30 ]
    To evaluate the pharmacokinetics (PK) of GLPG1205, nintedanib and pirfenidone in IPF subjects.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Subjects who meet all of the following criteria are eligible for the study:

  • Signed informed consent form (ICF) obtained prior to any study-related procedures and/or assessments performed.
  • Males or females of non-child-bearing potential, aged ≥40 years on the day of signing the ICF.
  • A diagnosis of IPF within 3 years prior to the screening visit as per American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines. Subjects receiving local standard of care, defined as nintedanib, pirfenidone, or neither nintedanib or pirfenidone. Also prednisone at steady dose ≤15 mg/day is allowed (stabilized 4 weeks prior to screening and continued without variation of dose or regimen). Supportive care like supplemental oxygen or pulmonary rehabilitation is allowed.
  • Meeting all of the following criteria at screening and during the screening period:

    • FVC ≥50% predicted of normal
    • Disease progression in the last 9 months prior to the screening period and at screening, defined as at least one prescreening FVC value and screening value with a decline of FVC (% predicted or mL), at the investigator's discretion
    • Diffusing capacity for the lungs for carbon monoxide (DLCO) ≥30% predicted of normal (corrected for hemoglobin)
    • Ratio of forced expiratory volume in one second (FEV1) to FVC ≥0.70
  • In a stable condition and suitable for study participation based on the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation. Stable condition is based on the clinical judgment of the investigator, co-morbidities should be treated according to the local applicable guidelines. Concomitant medication for comorbidities should be stabilized from 4 weeks before screening and during the screening period (stable defined as no change of dose or regimen).
  • Able to walk at least 150 meters during the 6MWT at screening; without having a contraindication to perform the 6MWT.

This list only describes the key inclusion criteria.

Exclusion criteria:

Subjects meeting one or more of the following criteria cannot be selected for this study:

  • Known hypersensitivity to any of the investigational medicinal product (IMP) ingredients or a history of a significant allergic reaction to any drug as determined by the investigator (e.g. anaphylaxis requiring hospitalization).
  • History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, congenital, acquired, medication induced).
  • Positive serology for hepatitis B (surface antigen and core antibody) or C (antibody), or any history of hepatitis from any cause with the exception of hepatitis A.
  • History of malignancy within the past 5 years (except for carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin that has been treated with no evidence of recurrence, and prostate cancer medically managed through active surveillance or watchful waiting, and squamous cell carcinoma of the skin if fully resected).
  • Acute IPF exacerbation within 3 months prior to screening and during the screening period.
  • Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
  • Interstitial lung disease associated with known primary diseases (e.g. sarcoidosis, amyloidosis), exposures (e.g. radiation, silica, asbestos, coal dust), and drugs (e.g. amiodarone).
  • History of lung volume reduction surgery or lung transplant.
  • Unstable cardiovascular, pulmonary (other than IPF) or other disease within 6 months prior to screening or during the screening period (e.g. coronary heart disease, heart failure, stroke).
  • Subject participating in a drug, device or biologic investigational research study, concurrently with the current study, or within 5-halflives of the agent (or within 8 weeks when half-life is unknown) prior to screening, or prior participation in an investigational drug antibody study within 6 months prior to screening.

This list only describes the key exclusion criteria.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725852


Contacts
Contact: Evelyn Fox 0032 15 34 29 00 evelyn.fox@glpg.com

Locations
Bulgaria
Specialized Hospital for Active Treatment Pleven Recruiting
Pleven, Bulgaria, 5800
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd. Recruiting
Ruse, Bulgaria, 7002
Slovakia
ZAPA JJ s.r.o. Recruiting
Levice, Slovakia, 934 01
Pľúcna Ambulancia Hrebenár, s.r.o. Recruiting
Spišská Nová Ves, Slovakia, 05201
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Christian Seemayer, MD Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03725852     History of Changes
Other Study ID Numbers: GLPG1205-CL-220
2017-004302-18 ( EudraCT Number )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial