A Phase 3 interventional study of Pamrevlumab and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by FibroGen. Terminated at 157 sites in 25 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by FibroGen · Phase 3, Interventional, and Treatment
Among 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States — 37 open to participants now, 51 under way, 8 of them phase 3. Idiopathic Pulmonary Fibrosis · United States.
Among the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, this one is the 25th largest by enrollment of the 188 interventional ones that give a count, is one of 14 that started in 2020, is one of 37 in phase 3, and was the 153rd registered.
577 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 124 are open to participants now.
Browse Idiopathic Pulmonary Fibrosis studies →37 of the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States are open now. Recruiting first, the newest first:
University of California, San Francisco · Sites in United States
Ages 18+
Oorja Bio, Inc. · Sites in United States
Ages 40+
Trevi Therapeutics · Sites in United States
Ages 40+
Joseph C. Wu · Sites in United States
Ages 40+
Chiesi Farmaceutici S.p.A. · Sites in United States, North Macedonia, Korea, Republic of and 1 more country
Ages 40+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 86 Idiopathic Pulmonary Fibrosis studies recruiting now, 56 (65%) set no upper age limit and 8 (9%) stop at 75 or younger; 3 take children under 18; 15 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
236 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 89 · Phase 3 39 · Phase 4 6
First in 1999; this study’s year is marked. 14 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 372 is above the median of 55 across 390 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Median enrollment 61 across the 188 interventional studies, 320 across the 45 observational. Of the 170 that completed or were terminated, 85 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
134 of 236 have an industry lead sponsor. The 10 most frequent:
This study is registered under FibroGen, one of the names counted as Kyntra Bio. Under that name alone:
FibroGen is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Kyntra Bio has 5 studies filed under Idiopathic Pulmonary Fibrosis — fewer than ten, so there is no comparison to draw.
15 of the studies in Idiopathic Pulmonary Fibrosis with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06238622Phase 3Boehringer IngelheimA Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast | 2027-04-28 |
| NCT07868419Phase 3Trevi TherapeuticsIdiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets | 2027-08 |
| NCT06736990Calluna Pharma ASA Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis | 2026-11 |
| NCT06853145University of VirginiaHyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis | 2026-12 |
| NCT03478553University of Colorado, DenverThe Genetics of Pulmonary Fibrosis | 2026-12-31 |
Add all 15 to your calendar (.ics) → With an account.
Among the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:
NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.
During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment.
Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks. Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks
Drug: Pamrevlumab
Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Drug: Placebo
Sterile solution for injection
Also known as: FG-3019
Sterile solution for injection
DB Period: Change From Baseline in FVC at Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).
Time frame: Baseline, Week 48
DB Period: Time to Disease Progression
Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
The QLF volume is calculated as QLF=total lung capacity volume (TLC) \* % of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE were analyzed using MMRM.
Time frame: Baseline, Week 48
DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First
The components of the clinical composite endpoints included acute idiopathic pulmonary fibrosis (IPF) exacerbation, respiratory hospitalization, or death. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Time to First Acute IPF Exacerbation
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Time to All-Cause Mortality
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Time to First Respiratory Hospitalization
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
| Milestone | Pamrevlumab | Placebo |
|---|---|---|
| Started | 184 | 188 |
| Received at least 1 dose of study drug | 183 | 188 |
| Completed | 47 | 56 |
| Not completed | 137 | 132 |
| Withdrew: Adverse event | 6 | 6 |
| Withdrew: Death | 14 | 11 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Investigator decision | 0 | 1 |
| Withdrew: Study terminated by sponsor | 99 | 101 |
| Withdrew: Disease progression | 1 | 0 |
| Withdrew: Withdrawal by subject | 11 | 7 |
| Withdrew: Lung transplant | 1 | 0 |
| Withdrew: Participant decision | 4 | 3 |
| Milestone | Pamrevlumab | Placebo |
|---|---|---|
| Started | 41 | 45 |
| Completed | 0 | 0 |
| Not completed | 41 | 45 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Death | 4 | 6 |
| Withdrew: Study terminated by sponsor | 34 | 37 |
| Withdrew: Withdrawal by subject | 0 | 1 |
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).
| liters | Pamrevlumab | Placebo |
|---|---|---|
| DB Period: Change From Baseline in FVC at Week 48 | -0.30 ± 0.057 | -0.33 ± 0.059 |
Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
| weeks | Pamrevlumab | Placebo |
|---|---|---|
| DB Period: Time to Disease Progression | 59.0 (NA to NA) | NA (49.4 to NA) |
The QLF volume is calculated as QLF=total lung capacity volume (TLC) \* % of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE were analyzed using MMRM.
| milliliters | Pamrevlumab | Placebo |
|---|---|---|
| DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48 | 255.14 ± 72.028 | 269.15 ± 60.898 |
The components of the clinical composite endpoints included acute idiopathic pulmonary fibrosis (IPF) exacerbation, respiratory hospitalization, or death. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
| weeks | Pamrevlumab | Placebo |
|---|---|---|
| DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First | NA (59.0 to NA) | NA (NA to NA) |
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
| weeks | Pamrevlumab | Placebo |
|---|---|---|
| DB Period: Time to First Acute IPF Exacerbation | NA (NA to NA) | NA (NA to NA) |
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
| weeks | Pamrevlumab | Placebo |
|---|---|---|
| DB Period: Time to All-Cause Mortality | NA (59.0 to NA) | 62.9 (NA to NA) |
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
| weeks | Pamrevlumab | Placebo |
|---|---|---|
| DB Period: Time to First Respiratory Hospitalization | NA (NA to NA) | NA (NA to NA) |
Collected over From first dose of study drug up to Week 104. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB Period: Pamrevlumab | 16/184 (8.7%) | 38/183 (20.8%) | 83/183 (45.4%) |
| DB Period: Placebo | 15/188 (8%) | 37/188 (19.7%) | 74/188 (39.4%) |
| OLE Period: Pamrevlumab | 12/86 (14%) | 20/86 (23.3%) | 21/86 (24.4%) |
| Event | DB Period: Pamrevlumab | DB Period: Placebo | OLE Period: Pamrevlumab |
|---|---|---|---|
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 9/183 | 10/188 | 12/86 |
| PneumoniaInfections and infestations | 9/183 | 10/188 | 0/86 |
| and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 3/183 | 2/188 | 2/86 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/183 | 1/188 | 2/86 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/183 | 1/188 | 0/86 |
| Acute coronary syndromeCardiac disorders | 0/183 | 0/188 | 1/86 |
| Cardiopulmonary failureCardiac disorders | 0/183 | 0/188 | 1/86 |
| Sudden deathGeneral disorders | 0/183 | 0/188 | 1/86 |
| Hepatic cirrhosisHepatobiliary disorders | 0/183 | 0/188 | 1/86 |
| Respiratory tract infectionInfections and infestations | 1/183 | 1/188 | 1/86 |
| Event | DB Period: Pamrevlumab | DB Period: Placebo | OLE Period: Pamrevlumab |
|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 26/183 | 24/188 | 5/86 |
| COVID-19Infections and infestations | 20/183 | 16/188 | 8/86 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 16/183 | 12/188 | 5/86 |
| DiarrhoeaGastrointestinal disorders | 14/183 | 15/188 | 4/86 |
| NasopharyngitisInfections and infestations | 13/183 | 14/188 | 4/86 |
| BronchitisInfections and infestations | 9/183 | 12/188 | 0/86 |
| AstheniaGeneral disorders | 11/183 | 7/188 | 4/86 |
| FatigueGeneral disorders | 11/183 | 5/188 | 0/86 |
The intent-to-treat (ITT) population included all randomized participants.
| Age, Continuous(years) | Pamrevlumab | Placebo | Total |
|---|---|---|---|
| Mean | 70.2 ± 7.8 | 70.1 ± 8.2 | 70.1 ± 8.0 |
| Sex: Female, Male(Participants) | Pamrevlumab | Placebo | Total |
|---|---|---|---|
| Female | 45 | 44 | 89 |
| Male | 139 | 144 | 283 |
| Ethnicity (NIH/OMB)(Participants) | Pamrevlumab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 52 | 45 | 97 |
| Not Hispanic or Latino | 125 | 141 | 266 |
| Unknown or Not Reported | 7 | 2 | 9 |
| Race (NIH/OMB)(Participants) | Pamrevlumab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 42 | 55 | 97 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 111 | 114 | 225 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 29 | 16 | 45 |
| Forced Vital Capacity (FVC)(liters) | Pamrevlumab | Placebo | Total |
|---|---|---|---|
| Mean | 2.4811 ± 0.6477 | 2.5097 ± 0.6573 | 2.4955 ± 0.6518 |
Showing the first 100 of 157 sites across 25 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2020 to primary completion in Sep 2023, 35 months.
Results were first posted in Aug 2024, 11 months after primary completion.
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This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pamrevlumab
Idiopathic Pulmonary Fibrosis →