Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

  • days left to enroll
  • participants needed
  • sponsor
Updated on 18 October 2022
carbon monoxide
idiopathic pulmonary fibrosis
diffusion capacity of the lung for carbon monoxide


This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/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 profile of pamrevlumab as monotherapy in participants with IPF who were previously treated with an approved therapy but who discontinued that therapy (possible reasons for discontinuation of approved therapy could include, but are not limited to, intolerance or disease progression), unless neither treatment is available in the host country.

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. However, since participants either tried and stopped treatment with an approved IPF therapy, or have no such treatment available, it is not expected that many participants will resume treatment with an approved IPF therapy during this study.

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.

Condition Idiopathic Pulmonary Fibrosis
Treatment Placebo, Pamrevlumab
Clinical Study IdentifierNCT04419558
Last Modified on18 October 2022


Yes No Not Sure

Inclusion Criteria

Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation
High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing
FVCpp value >45% and <95% at Screening and Day 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%
Previously treated with an approved IPF therapy (such as, pirfenidone or nintedanib) but discontinued at least 1 week prior to screening, unless neither treatment is available in the host country

Exclusion Criteria

Previous exposure to pamrevlumab
Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT
Female participants who are pregnant or nursing
Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study
Interstitial lung disease other than IPF
Sustained improvement in the severity of IPF
Other types of respiratory diseases that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study, including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall
Certain medical conditions, that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study (such as, myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or cancers)
Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening
Recent use of any investigational drugs or unapproved therapies, or participation in any clinical trial
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note