Idiopathic Pulmonary FibrosisPhase 2STRIVE IINCT07674745
Autoantibody Reduction Therapy for Progressive Idiopathic Pulmonary Fibrosis
A Phase 2 study testing Therapeutic Plasma Exchange, Rituximab and Intravenous immunoglobulin in people with Idiopathic Pulmonary Fibrosis, run by University of Alabama at Birmingham at 9 sites in United States.
Trial summary
This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Therapeutic Plasma Exchange, Rituximab and Intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Dec 2026to 31 Mar 2031
- Phase
- Phase 2
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-85 years old.
- A diagnosis of IPF that fulfills latest ATS/ERS Consensus Criteria.
- A diagnosis of Progressive IPF (P-IPF), defined as a relative decrease of FVC%p >10% during the preceding twelve months, and substantiated by replicate values at least three weeks apart.
- Ability and willingness to give informed consent (no surrogates) and adhere to requirements.
- Have eligibility confirmed by a consensus of trial investigators.
- Is not now or has been in experimental regimen for at least 2 weeks (or 5 half-lives of agent) and agrees to not become participants in other experimental regimens (other than solely observational registries) for the duration of their participation in this trial (180 days).
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- Has been immunized with 2025-2026 COVID-19 vaccine (and later versions as they become available) between 1 and 26 weeks prior to randomization.
- IPF duration <10 years, based on the date of definitive diagnosis.
- Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) >0.70
Who cannot join
- Diagnoses of current infection by clinical or microbial assessments.
- Diagnoses of an additional or alternative etiology for lung dysfunction based upon clinical assessment, including sepsis, congestive heart failure, thromboembolism, worsened pulmonary artery hypertension, etc. using routine clinical evaluations under direction of the attending physician.
- History or serologic evidence of hepatitis B or C infection. Positive serology for Hepatitis C will not exclude patients if their circulating HC virus RNA test is negative.
- Coagulopathy, defined as an INR >1.6, PTT >2x control, fibrinogen <100 mg/dL, or platelet count <50,000 unless these abnormalities can be reversed.
- Uncontrolled diabetes or hypertension (systolic BP >160 mm Hg and diastolic BP >100 mm Hg) that would contraindicate use of corticosteroids.
- Hemodynamic instability, defined as an inotrope or vasopressor requirement.
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- History of reactions to blood products, murine-derived products, or prior rituximab use within the last six months.
- History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen <10 ng/dl. AART is not known to promote cancer, and these criteria are within current guidelines.
- Unwillingness to accept blood product transfusion.
- Diagnosis of major comorbidities expected to interfere with study participation.
- Treatment for >14 days within the preceding month with >20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immuno-suppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), or with rituximab (or other anti-B-cell biological agents) within the last 6 months.
- Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and/or substituted (to obviate hemodynamic lability during TPE).
- Fertile women who do not agree to contraception or abstinence. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
- An alternative, concordant or historical diagnosis of interstitial lung diseases other than IPF, including idiopathic fibrosis with autoimmune features (IPAF) per clinical domain.1
- IgA deficiency, to preclude IVIg reactions.
- Listed with the United Network for Organ Sharing (UNOS) for lung transplant at the time of enrollment, to minimize the number of censoring due to very early transplants.
- Ongoing suspected or known acute exacerbations of IPF (AE-IPF), defined as new onset (within the last 30 days) of dyspnea with increased hypoxemia or oxygen requirement, and new radiographic infiltrates especially with ground glass opacities (GGO).
- Patients taking antifibrotic agents at randomization who have not been on a stable dose for at least 6 weeks: these therapies could be initiated, at the discretion of their attending physicians, at or after the midpoint of their participation in STRIVE II (i.e., three months after randomization).
- Patients whose oxygen requirements at rest (per an arterial oxygen saturation [SaO2] >0.92) cannot be met with simple nasal cannula at <10L/min.
- Patients who are not expected to survive 180 days or, in the opinion of the local attending physician, have a high likelihood of not tolerating the trial interventions due to underlying comorbidities or frailties.
- >10% of whole lung images are emphysematous on High Resolution CT scan
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Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Steven R. Duncan, MD, 4122156977, srduncan@uabmc.edu
Steven R Duncan, MD, 4122156977, srduncan@uabmc.edu
University of North Carolina
Chapel Hill, North Carolina, 27599
Sean Callahan, MD, 919-966-2531, sean_callahan@med.unc.edu
Sean Callahan, MD
Loyola University
Chicago, Illinois, 60153
Dan Dilling, MD, 773-793-3594, ddillin@lumc.edu
Daniel Dilling, MD
Northwestern University
Chicago, Illinois, 60611
Anthony Esposito, MD, 256-231-0022, anthony.esposito@northwestern.edu
Anthony Esposito, MD
University of Kansas
Kansas City, Kansas, 60611
Mark Hamblin, MD, 913-588-6045, mhamblin@kumc.edu
Mark Hamblin, MD
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Ross Summer, MD, 617-680-8966, ross.summer@jefferson.edu
Ross Summer, MD
Temple University
Philadelphia, Pennsylvania, 19140
Gerald R. Criner, MD, 215-5106570, gerard.criner@tuhs.temple.edu
Gerald R Criner, MD, 215-510-6570, gerald.criner@tuhs.temple.edu
University of Pittsburgh
Pittsburgh, Pennsylvania, 60611
Dan Kass, MD, 917-687-4592, kassd2@upmc.edu
Dan Kass, MD, 917-887-4592, kassd2@upmc.edu
University of Utah
Salt Lake City, Utah, 84132
Mary Beth Scholand, MD, 801-657-2370, mary.beth.scholand@hsc.utah.edu
Mary Beth Scholand, MD
About this study
Official title: Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)
This Phase IIb trial will compare effectiveness and safety of a multi-component autoantibody reduction therapy (AART), consisting of therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIg) for treatment of patients with progressive idiopathic pulmonary fibrosis (IPF).
Read the detailed description
Patients with progressive pulmonary fibrosis, identified at any of nine participating leading U.S. medical centers, will be randomized (by computer) in a 1:1 ratio to either AART or treatment as usual (TAU). Stratification factors for randomization are sex (self-identified) and whether or not patients are taking any IPF-approved medication. Patients will be observed for six (6) months, with observations and assessments made at baseline, 30 days after randomization, and 90 and 180 days after randomization.
Data will be electronically submitted via electronic case report forms (eCRF) to a Data Coordinating Center.
The University of Alabama Medical Center Institutional Review Board (IRB) will be the central IRB for all sites.
Specimens collected will also be used in experimental B-cell studies conducted in the laboratory of the Principal Investigator.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Therapeutic Plasma Exchange, Rituximab, Intravenous immunoglobulin, Treatment as Usual
- Keywords
- Progression, Autoantibodies
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Plasma ExchangeOther
Also called Plasmapheresis
Removal of patient's plasma by mechanical means and replacement with saline and albumin or normal plasma
RituximabDrug
Also called ritux
Infusion of humanized mouse monoclonal antibody with specificity for human CD20
Intravenous immunoglobulinDrug
Also called IVIg
intravenous infusions of normal human immunoglobulin
Continued therapy with conventional, approved, specific IPF medications
| Study group | Role | What they receive |
|---|---|---|
| Autoantibody Reduction Therapy (AART) | Experimental | Patients will be treated with combination of five (5) therapeutic plasma exchanges, followed by one dose of rituximab and then followed with four infusions of intravenous immunoglobulin (IVIg) Receives: Other: Therapeutic Plasma Exchange; Drug: Rituximab; Drug: Intravenous immunoglobulin |
| Treatment as Usual (TAU) | Active comparator | Patients will continue treatment(s) with optimized approved medications for idiopathic pulmonary fibrosis (IPF) Receives: Drug: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Intergroup comparisons of FVC changes over duration of observations
Measured: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Secondary outcomes (4)
Supplemental Oxygen Requirements (O2)
Intergroup comparisons of changing O2 requirements over duration of observations
Measured: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Six-minute walk distances (6MWD)
Intergroup comparisons of changes of 6MWD over duration of observations
Measured: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Durations of progression-free survival
Intergroup comparisons of number who survive without >5% decrements of FVC as percent of predicted normal values
Measured: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Composite outcome measure
Absolute numbers of acute IPF exacerbations or all cause deaths or unscheduled hospitalizations
Measured: 180 days or latest available observation (e.g., at 30, 90, or 180 days after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University of Alabama at BirminghamThe 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
- Model description
- Randomized to experimental treatment (autoantibody reduction therapy- AART) or Treatment as Usual- 2 arms
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven R. Duncan, MD, University of Alabama at Birmingham
- Investigators
- Steven R Duncan, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674745
- Sponsor's protocol ID
- IRB-300016700
- Other IDs
- PR251064
- Acronym
- STRIVE II
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Any shared data would need to be de-identified, shared only with qualified researchers and otherwise be sanctioned by university regulations.
Publications
Donahoe M, Valentine VG, Chien N, Gibson KF, Raval JS, Saul M, Xue J, Zhang Y, Duncan SR. Autoantibody-Targeted Treatments for Acute Exacerbations of Idiopathic Pulmonary Fibrosis. PLoS One. 2015 Jun 17;10(6):e0127771. doi: 10.1371/journal.pone.0127771. eCollection 2015.
PubMed 26083430Kulkarni T, Criner GJ, Kass DJ, Rosas IO, Scholand MB, Dilling DF, Summer R, Duncan SR. Design of the STRIVE-IPF trial- study of therapeutic plasma exchange, rituximab, and intravenous immunoglobulin for acute exacerbations of idiopathic pulmonary fibrosis. BMC Pulm Med. 2024 Mar 20;24(1):143. doi: 10.1186/s12890-024-02957-3.
PubMed 38509495