A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT02550873
Last Updated: 2022-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2015-09-01
2017-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PRM-151 10mg / kg
Dosing Every 4 Weeks
PRM-151
PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks
Placebo
Dosing Every 4 weeks
placebo
Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks
Interventions
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PRM-151
PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks
placebo
Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks
Eligibility Criteria
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Inclusion Criteria
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
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%.
40 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Bernt van den Blink, MD, PhD
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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UCSF Interstitial Lung Disease Program
San Francisco, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UT - Southwestern Medical School
Dallas, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Thomayer Hospital
Prague, , Czechia
Justus-Liebig University Giessen
Giessen, , Germany
Thoraxklinik University of Heidelberg
Heidelberg, , Germany
Az. Ospedaliera Universitaria-Policlinico V. Emanuele di Catania
Catania, , Italy
Azienda Ospedaliera San Gerardo
Monza, , Italy
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Hospital University de Bellvitge
Barcelona, , Spain
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
Countries
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References
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Raghu G, van den Blink B, Hamblin MJ, Brown AW, Golden JA, Ho LA, Wijsenbeek MS, Vasakova M, Pesci A, Antin-Ozerkis DE, Meyer KC, Kreuter M, Santin-Janin H, Mulder GJ, Bartholmai B, Gupta R, Richeldi L. Effect of Recombinant Human Pentraxin 2 vs Placebo on Change in Forced Vital Capacity in Patients With Idiopathic Pulmonary Fibrosis: A Randomized Clinical Trial. JAMA. 2018 Jun 12;319(22):2299-2307. doi: 10.1001/jama.2018.6129.
Raghu G, Hamblin MJ, Brown AW, Golden JA, Ho LA, Wijsenbeek MS, Vasakova M, Pesci A, Antin-Ozerkis DE, Meyer KC, Kreuter M, Burgess T, Kamath N, Donaldson F, Richeldi L. Long-term evaluation of the safety and efficacy of recombinant human pentraxin-2 (rhPTX-2) in patients with idiopathic pulmonary fibrosis (IPF): an open-label extension study. Respir Res. 2022 May 21;23(1):129. doi: 10.1186/s12931-022-02047-0.
Raghu G, van den Blink B, Hamblin MJ, Brown AW, Golden JA, Ho LA, Wijsenbeek MS, Vasakova M, Pesci A, Antin-Ozerkis DE, Meyer KC, Kreuter M, Moran D, Santin-Janin H, Aubin F, Mulder GJ, Gupta R, Richeldi L. Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study. Lancet Respir Med. 2019 Aug;7(8):657-664. doi: 10.1016/S2213-2600(19)30172-9. Epub 2019 May 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PRM-151-202
Identifier Type: OTHER
Identifier Source: secondary_id
2014-004782-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA42404
Identifier Type: -
Identifier Source: org_study_id
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