Rituximab Therapy in Patients With Treatment Refractory Hypersenstivity Pneumonitis

NCT07035561 | Completed Phase 2

• 1 other identifier: MD-180-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hypersensitivity pneumonitis (HP) presents with a highly variable clinical course, and Traditional treatment involves systemic corticosteroids in conjunction with strict avoidance of the offending antigen. However, a subset of patients with progressive disease remains unresponsive to conventional therapies. The objective of this study is to evaluate the therapeutic potential of Rituximab in individuals with refractory hypersensitivity pneumonitis who did not respond to conventional immunosuppressive therapy and antigen avoidance. Assessing FVC at three intervals: six months prior to the initiation of Rituximab therapy (M-6), at the time of treatment initiation (M0), and six months afterward (M+6).

Conditions

Hypersenstivity Pneumonitis; ILD

Keywords

Rituximab; FVC; Hypersenstivity Pneumonitis; treatment

Outcome Measures

Primary Outcomes (1)

• Change in FVC (% of the predicted value) in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy.

  Forced Vital Capacity (FVC) measured 6 months before rituximab therapy onset (M - 6), at rituximab onset (M0), and 6 months after rituximab intiation (M+6). The FVC% predicted change across treatment time points will be assessed to identify if Rituximab demonstrates potential as an effective treatment for individuals with hypersensitivity pneumonitis unresponsive to conventional therapy.

  From enrollment to the end of treatment and follow up of the clinical and functional status 18 months

Secondary Outcomes (2)

• Change in 6MWD in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy.

  From the onset of Rituximab therapy (M0) till 6 months after the onset of therapy (M+6)

• Change in Dyspnea grade by mMRC scale in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy.

  From the onset of Rituximab therapy (M0) till 6 months after the onset of therapy (M+6)

Study Arms (1)

Rituximab in treatment refractory Hypersenstivity pneumonitis

EXPERIMENTAL

Patients diagnosed with chronic Hypersensitivity Pneumonitis who have not responded to standard treatment including antigen avoidance and immunosuppressive therapy.

Drug: Rituximab (Mabthera)

Interventions

Rituximab (Mabthera) DRUG

In Chronic hypersensitivity pneumonitis patients with no improvement in lung function (deterioration in their FVC% predicted more than or equal 5%) after a minimum of 6 months treatment including antigen avoidance and immunosuppressive therapy. Rituximab will be administered by an intravenous infusion. * Two doses of Rituximab will be given, the first dose at day 0 and the second dose at day 15, 1 gram of Rituximab will be given in each dose. * Patients will be given acetaminophen and antihistamine before each infusion. * Rituximab will be diluted in an infusion bag of either 0.9% sodium chloride or 5% dextrose. * No other drugs will be mixed with it, and patients will be closely monitored for any infusion reactions.

Rituximab in treatment refractory Hypersenstivity pneumonitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old and above.
• Patients with the diagnosis of chronic hypersensitivity pneumonitis, validated during a multidisciplinary team meeting with the criteria adapted from the CHEST guidelines, with decline in their FVC of greater than or equal 5% after a minimum of 6 months treatment including antigen avoidance and immunosuppressive therapy (including corticosteroids and Azathioprine).

You may not qualify if:

• Hypersensitivity to Rituximab.
• Severe heart failure.
• Moderate or severe pulmonary hypertension.
• Fibrotic hypersensitivity pneumonitis.
• Pregnancy.
• Active infection.

Sponsors & Collaborators

• Shereen Medhat Mohammed Elsayed Nassar: lead

Study Sites (1)

Kasr Al Ainy, Cairo University's Faculty of Medicine

Cairo, Cairo Governorate, 11956, Egypt

Location

Related Publications (1)

• Akl Y, Kaddah SZ, Nassar SM, El Said RK. Rituximab therapy in patients with treatment-refractory hypersensitivity pneumonitis. Sci Rep. 2025 Oct 17;15(1):36460. doi: 10.1038/s41598-025-21463-y.

  PMID: 41107382 DERIVED

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yosri M. Akl, Professor of Chest Diseases

  Cairo University

  STUDY CHAIR

• Safy Z. Kaddah, Professor of Chest Diseases

  Cairo University

  STUDY DIRECTOR

• Rana K Gabr, MD in Chest Diseases

  Cairo University

  PRINCIPAL INVESTIGATOR

• Sherin M. Nassar, MSc in Chest Diseases

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shereen Medhat Mohammed Elsayed Nassar was the principle investigator

Model Details: * Rituximab will be administered by an intravenous infusion. * Two doses of Rituximab will be given, the first dose at day 0 and the second dose at day 15, 1 gram of Rituximab will be given in each dose. * Patients will be given acetaminophen and antihistamine before each infusion. * Rituximab will be diluted in an infusion bag of either 0.9% sodium chloride or 5% dextrose. * No other drugs will be mixed with it, and patients will be closely monitored for any infusion reactions.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: June 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

EG (1)