Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

1/2 Efficacy and Safety of Obinutuzumab in Connective Tissue Disease-Related Interstitial Lung Disease

Award Number: UG3HL183035
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/04/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2031

Group Awards By:

View Award Description

1/2 Efficacy and Safety of Obinutuzumab in Connective Tissue Disease-Related Interstitial Lung Disease - PROJECT SUMMARY/ABSTRACT Interstitial lung disease (ILD) is a frequent cause of morbidity and a leading cause of death among patients with connective tissue disease (CTD). The current standard of care with the immunosuppressant mycophenolate lacks support from well-designed clinical trials. Anti-B cell monoclonal antibody therapy is considered a valuable treatment choice in cases of progressive ILD due to CTD and is often used off-label (not FDA-approved) as rescue or upfront combination therapy with mycophenolate. Obinutuzumab, a second-generation anti-B cell monoclonal antibody engineered to overcome the limitations of rituximab (the prototypical anti-B cell monoclonal antibody), has demonstrated superior efficacy in depleting B cells, pivotal in CTD pathogenesis, with a similar safety profile. Clinical experience and lower-quality study data suggest the benefits of anti-B cell therapy in CTD- ILD patients. However, high-quality trial data supporting the efficacy of this therapeutic approach are lacking. A rigorously designed, systematically implemented therapeutic trial of anti-B cell therapy would fill this knowledge gap. We aim to fill this gap by conducting a two-phase project culminating in a phase II trial to evaluate the efficacy and safety of Obinutuzumab 1g IV on days 1 and 15 in treating patients with CTD-ILD on background mycophenolate. Phase 1 is a one-year UG3 planning grant to develop the necessary study infrastructure, research protocols and documents in close collaboration with NHLBI. Phase 2 is a four-year UH3 during which we will conduct a 24-week trial to test the hypothesis that patients on mycophenolate treated with Obinutuzumab will have an improved FVC mL at 24 weeks and similar adverse event rate compared to those in the mycophenolate control group. This hypothesis will be tested in a phase II, multicenter, randomized, placebo- controlled, double-blind trial that will employ a covariate-adaptive Bayesian design incorporating data borrowed from historical controls on mycophenolate from two trials, the Scleroderma Lung Study II trial and the EVER-ILD trial. Specific aims include: i) The primary endpoint is to establish the efficacy of Obinutuzumab in the treatment of CTD-ILD, ii) The secondary endpoints are to compare safety profiles and progression-free survival between arms, and iii) The exploratory endpoints are evaluating functional parameters and patient-reported outcome measures, as well as to determining whether chest CT patterns, quantitative CT extent of disease, and peripheral blood B- and T-cell subtypes can act as biomarker predicting the response to Obinutuzumab in CTD-ILD patients. This study is highly significant as it has the potential to establish Obinutuzumab as a novel, effective, and safe treatment option for patients with CTD-ILD by improving and preserving patients' lung function and health-related quality of life while also reducing the risk and cost of disease progression. Relevance to Public Health: Data from the proposed study could facilitate the early detection of high-risk patients and pave the way for establishing Obinutuzumab as an effective and safe treatment option, significantly impacting the clinical management of future patients with CTD-ILD.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,000,770 )
2026	2026	NATIONAL JEWISH HEALTH	1400 JACKSON ST	DENVER	CO	80206	DENVER	USA	Lung Diseases Research	000	1	9/8/2026	NEW	$1,000,770
														Subtotal = $1,000,770

Grand Total All Awards = $1,000,770

Top

All Categories

About

Search

Reports

Data Submission

Award Information

1/2 Efficacy and Safety of Obinutuzumab in Connective Tissue Disease-Related Interstitial Lung Disease

Award Number: UG3HL183035

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/04/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2031

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer