A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

NCT02550873 | Completed Phase 2 Results DMC

• 3 other identifiers: WA42404PRM-151-2022014-004782-24
• Study Type: interventional
• Target: 117
• Locations: 7 countries
• Sites: 18

Brief Summary

This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]

  Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.

  0 to 28 weeks

Secondary Outcomes (23)

• Change From Baseline in 6-Minute Walk Distance (6MWD)

  0 to 28 weeks

• Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT)

  0 to 28 weeks

• Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT

  0 to 28 weeks

• Change From Baseline in % of Total Lung Volume of ILA on HRCT

  0 to 28 weeks

• Change From Baseline in Volume of Normal Lung on HRCT

  0 to 28 weeks

Other Outcomes (1)

• Change From Baseline in FVC Volume

  0 to 28 weeks

Study Arms (2)

PRM-151 10mg / kg

EXPERIMENTAL

Dosing Every 4 Weeks

Biological: PRM-151

Placebo

PLACEBO COMPARATOR

Dosing Every 4 weeks

Other: placebo

Interventions

PRM-151 BIOLOGICAL

PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks

PRM-151 10mg / kg

placebo OTHER

Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is aged 40-80 years.
• 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.
• 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.
• If not currently receiving pirfenidone or nintedanib, subject must have been off pirfenidone or nintedanib for ≥ 4 weeks before baseline.
• Has a FVC ≥ 50% and ≤ 90% of predicted.
• Has a DLCO ≥ 25% and ≤ 90% of predicted.
• Minimum distance on 6-Minute Walk Test (6MWT) of 150 meters.
• Has a forced expiratory volume in 1 second (FEV1)/FVC ratio \> 0.70.
• 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.
• Has a life expectancy of at least 9 months
• According to the investigator's best judgment, can comply with the requirements of the protocol.
• Has provided written informed consent to participate in the study.

You may not qualify if:

• 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.
• Has a history of cigarette smoking within the previous 3 months.
• Has received investigational therapy for IPF within 4 weeks before baseline.
• Is receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks of baseline.
• Received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline.
• 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.
• 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.
• Has baseline resting oxygen saturation of \< 89% on room air or supplemental oxygen.
• 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.
• Has a known post bronchodilator (short acting beta agonist \[SABA\] - albuterol or salbutamol) increase in FEV1 of \>10% and in FVC of \>7.5%.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (18)

UCSF Interstitial Lung Disease Program

San Francisco, California, 94143, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UT - Southwestern Medical School

Dallas, Texas, 75930, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53715, United States

Location

Thomayer Hospital

Prague, 14059, Czechia

Location

Justus-Liebig University Giessen

Giessen, D-35392, Germany

Location

Thoraxklinik University of Heidelberg

Heidelberg, D-69126, Germany

Location

Az. Ospedaliera Universitaria-Policlinico V. Emanuele di Catania

Catania, 78-95123, Italy

Location

Azienda Ospedaliera San Gerardo

Monza, 20900, Italy

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Hospital University de Bellvitge

Barcelona, 08907, Spain

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, CH-1011, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 29800034 RESULT

• 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.

  PMID: 35597980 DERIVED

• 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.

  PMID: 31122893 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

PRM-151

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Study not designed to test secondary outcome measures. Diagnosis of IPF allowed "possible usual interstitial pneumonia." HRCTs read locally, so reads may be heterogeneous. HRCTs are susceptible to inspiratory effort artifacts.

Results Point of Contact

• Title: Renu Gupta, MD, Chief Medical Officer
• Organization: Promedior Inc.

rgupta@promedior.com

856-722-9824

Study Officials

• Bernt van den Blink, MD, PhD

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 16, 2015
• Study Start: September 1, 2015
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: May 2, 2022
• Results First Posted: December 14, 2018

Record last verified: 2022-03

Locations

DE (2); IT (2); CZ (1); NL (1); ES (1); US (10); CH (1)