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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02550873
Date of registration: 27/08/2015
Prospective Registration: Yes
Primary sponsor: Hoffmann-La Roche
Public title: A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Scientific title: A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Date of first enrolment: September 7, 2015
Target sample size: 117
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02550873
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
Belgium Czech Republic Czechia Germany Israel Italy Netherlands Spain
Switzerland United Kingdom United States
Contacts
Name:     Bernt van den Blink, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Hoffmann-La Roche
Key inclusion & exclusion criteria

Inclusion Criteria

1. Is aged 40-80 years.

2. Has IPF satisfying the American Thoracic Society/European Respiratory Society
/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT)
diagnostic criteria (Raghu, Collard et al. 2011). In the absence of a surgical lung
biopsy, high-resolution computed tomography (HRCT) must be "consistent with "usual
interstitial pneumonia" (UIP) defined as meeting either criteria A, B, and C, or
criteria A and C, or criteria B and C below:

- Definite honeycomb lung destruction with basal and peripheral predominance.

- Presence of reticular abnormality AND traction bronchiectasis consistent with
fibrosis, with basal and peripheral predominance.

- Atypical features are absent, specifically nodules and consolidation. Ground
glass opacity, if present, is less extensive than reticular opacity pattern.

3. If on pirfenidone or nintedanib, subject must have been on a stable dose of
pirfenidone or nintedanib for at least 3 months without increase in forced vital
capacity (FVC)% predicted on two consecutive pulmonary function tests (PFTs),
including screening PFTs. Subjects may not be on both pirfenidone and nintedanib.

4. If not currently receiving pirfenidone or nintedanib, subject must have been off
pirfenidone or nintedanib for = 4 weeks before baseline.

5. Has a FVC = 50% and = 90% of predicted.

6. Has a DLCO = 25% and = 90% of predicted.

7. Minimum distance on 6-Minute Walk Test (6MWT) of 150 meters.

8. Has a forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.70.

9. Women of child bearing potential (WCBP), defined as a sexually mature woman not
surgically sterilized or not post-menopausal for at least 24 consecutive months if =
55 years or 12 months if > 55 years, must have a negative serum pregnancy test within
four weeks prior to the first dose of study drug and must agree to use adequate
methods of birth control throughout the study. Adequate methods of contraception are
defined in the protocol.

10. Has a life expectancy of at least 9 months

11. According to the investigator's best judgment, can comply with the requirements of the
protocol.

12. Has provided written informed consent to participate in the study.

Exclusion Criteria:

1. Has emphysema = 50% on HRCT or the extent of emphysema is greater than the extent of
fibrosis according to reported results from the most recent HRCT.

2. Has a history of cigarette smoking within the previous 3 months.

3. Has received investigational therapy for IPF within 4 weeks before baseline.

4. Is receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or
equivalent within 2 weeks of baseline.

5. Received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.

6. Has a history of a malignancy within the previous 5 years, with the exception of basal
cell skin neoplasms. In addition, a malignant diagnosis or condition first occurring
prior to 5 years must be considered cured, inactive, and not under current treatment.

7. Has any concurrent condition other than IPF that, in the Investigator's opinion, is
unstable and/or would impact the likelihood of survival for the study duration or the
subject's ability to complete the study as designed, or may influence any of the
safety or efficacy assessments included in the study.

8. Has baseline resting oxygen saturation of < 89% on room air or supplemental oxygen.

9. Is unable to refrain from use of the following:

- Short acting bronchodilators on the day of and within 12 hours of pulmonary
function, DLCO, and 6 minute walk assessments.

- Long acting bronchodilators on the day of and within 24 hours of these
assessments.

10. Has a known post bronchodilator (short acting beta agonist [SABA] - albuterol or
salbutamol) increase in FEV1 of >10% and in FVC of >7.5%.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Idiopathic Pulmonary Fibrosis
Intervention(s)
Biological: PRM-151
Other: placebo
Primary Outcome(s)
Change From Baseline in Forced Vital Capacity (FVC) [% Predicted] [Time Frame: 0 to 28 weeks]
Secondary Outcome(s)
All Cause Mortality [Time Frame: 0 to 28 weeks]
Change From Baseline in % of Normal Lung on HRCT (%) [Time Frame: 0 to 28 weeks]
Change From Baseline in % of Total Lung Volume of ILA on HRCT [Time Frame: 0 to 28 weeks]
Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO). [Time Frame: 0 to 28 weeks]
Change From Baseline in 6-Minute Walk Distance (6MWD) [Time Frame: 0 to 28 weeks]
Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT) [Time Frame: 0 to 28 weeks]
Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT [Time Frame: 0 to 28 weeks]
Change From Baseline in Volume of Normal Lung on HRCT [Time Frame: 0 to 28 weeks]
Correlation Between Mean Change From Baseline in FVC [% Predicted] and Mean Change From Baseline in ILA [Time Frame: 0 to 28 weeks]
Mortality Due to Disease Related Events [Time Frame: 0 to 28 weeks]
Mortality Due to Respiratory Deterioration [Time Frame: 0 to 28 weeks]
Number of Subjects With a Decline in FVC [% Predicted] of = 5% and = 10% From Baseline to Week 28. [Time Frame: 0 to 28 weeks]
Number of Subjects With a Decline in FVC of = 100 mL and = 200 mL From Baseline to Week 28. [Time Frame: 0 to 28 weeks]
Number of Subjects With an Increase in FVC [% Predicted] of = 5% and =10% From Baseline to Week 28. [Time Frame: 0 to 28 weeks]
Number of Subjects With an Increase in FVC of = 100 mL and = 200 mL From Baseline to Week 28 [Time Frame: 0 to 28 weeks]
Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28. [Time Frame: 0 to 28 weeks]
Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28. [Time Frame: 0 to 28 weeks]
Percentage of Subjects Discontinuing Study Drug Due to AEs [Time Frame: 0 to 28 weeks]
Percentage of Subjects Reporting Respiratory Decline AEs [Time Frame: 0 to 28 weeks]
Percentage of Subjects Reporting Respiratory Decline SAEs [Safety and Tolerability] [Time Frame: 0 to 28 weeks]
Percentage of Subjects Reporting Serious Adverse Events (SAEs) [Time Frame: 0 to 28 weeks]
Percentage of Subjects With Infusion Related Reactions [Time Frame: 0 to 28 weeks]
Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) [Time Frame: 0 to 28 weeks]
Secondary ID(s)
PRM-151-202
WA42404
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 14/12/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02550873
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