Idiopathic Pulmonary FibrosisPhase 2NCT02550873
A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing PRM-151 in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 18 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- PRM-151
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 1 Sep 2015to 2 May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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%.
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
UT - Southwestern Medical School
Dallas, Texas, 75930
National Jewish Medical and Research Center
Denver, Colorado, 80206
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Louisville Hospital
Louisville, Kentucky, 40202
University of Wisconsin-Madison
Madison, Wisconsin, 53715
Yale University School of Medicine
New Haven, Connecticut, 06520
UCSF Interstitial Lung Disease Program
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98195
Germany2 sites
Justus-Liebig University Giessen
Giessen, D-35392
Thoraxklinik University of Heidelberg
Heidelberg, D-69126
Italy2 sites
Az. Ospedaliera Universitaria-Policlinico V. Emanuele di Catania
Catania, 78-95123
Azienda Ospedaliera San Gerardo
Monza, 20900
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 CE
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, CH-1011
About this study
Official title: A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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.
Read the detailed description
PRM-151 is an anti-fibrotic immunomodulator being developed for treatment of fibrotic diseases.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- PRM-151, placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRM-151Biological
PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks
placeboOther
Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PRM-151 10mg / kg | Experimental | Dosing Every 4 Weeks Receives: Biological: PRM-151 |
| Placebo | Placebo comparator | Dosing Every 4 weeks Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 28 weeks
Secondary outcomes (23)
Change From Baseline in 6-Minute Walk Distance (6MWD)
Measured: 0 to 28 weeks
Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT)
Mean change from baseline in total lung volume on HRCT using quantitative imaging software.
Measured: 0 to 28 weeks
Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT
Mean change from baseline in volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software
Measured: 0 to 28 weeks
Change From Baseline in % of Total Lung Volume of ILA on HRCT
Mean change from baseline in % of total lung volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software
Measured: 0 to 28 weeks
Change From Baseline in Volume of Normal Lung on HRCT
Mean change from baseline in volume of parenchymal features on HRCT representative of normal lung (non-ILA), including normal and mild low attenuation areas, using quantitative imaging software.
Measured: 0 to 28 weeks
Change From Baseline in % of Normal Lung on HRCT (%)
Mean change from baseline in % of total lung volume of parenchymal features on HRCT representative of normal lung (non-ILA), including normal and mild low attenuation areas, using quantitative imaging software.
Measured: 0 to 28 weeks
Correlation Between Mean Change From Baseline in FVC [% Predicted] and Mean Change From Baseline in ILA
Correlation between mean change from Baseline in FVC [% predicted] and mean change from Baseline in volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing by quantitative imaging software.
Measured: 0 to 28 weeks
Number of Subjects With a Decline in FVC [% Predicted] of ≥ 5% and ≥ 10% From Baseline to Week 28.
Pulmonary Function Tests for the Proportion (%) of subjects with a decline in FVC% predicted of ≥ 5% and ≥ 10% from Baseline to Week 28.
Measured: 0 to 28 weeks
Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28.
Measured: 0 to 28 weeks
Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28.
Measured: 0 to 28 weeks
Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28
Measured: 0 to 28 weeks
Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28.
Measured: 0 to 28 weeks
Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28.
Measured: 0 to 28 weeks
Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO).
Pulmonary Function Tests to discern the mean change from Baseline to Week 28 in % predicted diffusion capacity of carbon monoxide (DLCO).
Measured: 0 to 28 weeks
Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Tolerability/safety was assessed over the 28-week study period by the number of reported TEAEs
Measured: 0 to 28 weeks
Percentage of Subjects Discontinuing Study Drug Due to AEs
Tolerability/safety was assessed over the 28-week study period by the proportion of subjects who discontinued study drug due to AEs
Measured: 0 to 28 weeks
Percentage of Subjects Reporting Serious Adverse Events (SAEs)
Tolerability/safety was assessed over the 28-week study period by incidence of SAEs
Measured: 0 to 28 weeks
Percentage of Subjects Reporting Respiratory Decline AEs
Tolerability/safety was assessed over the 28-week study period by the number of reported respiratory decline AEs, defined as follows:
- Unscheduled visits to a healthcare professional for respiratory status deterioration.
- Urgent care visits for respiratory status deterioration.
- Hospitalization due to a worsening or exacerbation of respiratory symptoms.
Measured: 0 to 28 weeks
Percentage of Subjects Reporting Respiratory Decline SAEs [Safety and Tolerability]
Tolerability/safety was assessed over the 28-week study period by the number of reported serious respiratory decline AEs
Measured: 0 to 28 weeks
Percentage of Subjects With Infusion Related Reactions
Infusion Related Reactions were defined as events of headache, fever, facial flushing, pruritus, myalgia, nausea, chest tightness, dyspnea, vomiting, erythema, abdominal discomfort, diaphoresis, shivers, hypertension, hypotension, lightheadedness, palpitations, urticaria and somnolence occurring between the start of a study treatment infusion and one hour after completion of the infusion.
Measured: 0 to 28 weeks
All Cause Mortality
Tolerability/safety was assessed over the 28-week study period by the incidence of all cause mortality
Measured: 0 to 28 weeks
Mortality Due to Respiratory Deterioration
Tolerability/safety was assessed over the 28-week study period by the incidence of mortality due to respiratory deterioration
Measured: 0 to 28 weeks
Mortality Due to Disease Related Events
Number of patients who died over the 28 week study period due to disease-related events (defined as cough, IPF exacerbation, IPF progression and respiratory decline AEs)
Measured: 0 to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion2 May 2017
- Study completion2 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernt van den Blink, MD, PhD, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550873
- Sponsor's protocol ID
- WA42404
- Other IDs
- PRM-151-202, 2014-004782-24, 2014
- Status last verified
- Mar 2022
- First submitted
- 27 Aug 2015
- Last updated
- 2 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29800034Raghu 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.
PubMed 35597980Raghu 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.
PubMed 31122893
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT02550873
- Acronym / sponsor ID
- WA42404
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRM-151 is an anti-fibrotic immunomodulator being developed for treatment of fibrotic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRM-151 10mg / kg | Experimental | Biological: PRM-151Dosing Every 4 Weeks |
| Placebo | Placebo comparator | Other: placeboDosing Every 4 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRM-151PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | Biological | PRM-151 10mg / kg |
| placeboPlacebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | Other | Placebo |
Primary outcome
Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]
Time frame: 0 to 28 weeks
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.
23 secondary outcomes
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 % of Total Lung Volume of 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
Change From Baseline in % 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
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
Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO).
Time frame: 0 to 28 weeks
Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
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 Serious Adverse Events (SAEs)
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 With Infusion Related Reactions
Time frame: 0 to 28 weeks
All Cause Mortality
Time frame: 0 to 28 weeks
Mortality Due to Respiratory Deterioration
Time frame: 0 to 28 weeks
Mortality Due to Disease Related Events
Time frame: 0 to 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29800034Raghu 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.
- Derived from this study: PubMed 35597980Raghu 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.
- Derived from this study: PubMed 31122893Raghu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernt van den Blink, MD, PhD study director
Hoffmann-La Roche
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRM-151 in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Germany, Italy, Czechia, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Forced Vital Capacity (FVC) [% Predicted] (time frame: 0 to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550873, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.