A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease

Study Purpose

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria for all Participants:

- FVC ≥45% predicted during screening as determined by the over-reader.

- Forced expiratory volume in 1 second (FEV1)/FVC ratio >0.70 during screening as determined by the over-reader.

- DLco ≥30% and ≤90% of predicted during screening (Hgb corrected) as determined by the over-reader.

- Minimum 6-MWT distance of 150 m with maximum use of 6 liters per minute (L/min) at sea-level and up to 8 L/min at altitude (> 5000 feet [1524 m] above sea level) of supplemental oxygen while maintaining oxygen saturation of >83% during the 6MWT during screening.

- Participant and investigator consideration of all medicinal treatment options and/or possibly lung transplantation prior to consideration of participation in the study.

Inclusion Criteria for Cohort 1:

- Age 40-85 years.

- Documented diagnosis of IPF or IPF (likely) - HRCT pattern consistent with the diagnosis of IPF, confirmed by central review of chest HRCT and central review of any available lung biopsy.

- For participants receiving pirfenidone or nintedanib treatment for IPF: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with plans to continue treatment during the study period.

Inclusion Criteria for Cohort 2:

- Age 18-85 years.

- Diagnosis of SSc as defined using the American College of Rheumatology/European Alliance of Associations for Rheumatology (EULAR) criteria.

- HRCT demonstrating ≥10% extent of fibrosis, confirmed by central review of Chest HRCT.

- Evidence of progression of pulmonary fibrosis.

- For participants receiving tocilizumab treatment for SSc-ILD: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study.

- For participants receiving nintedanib treatment for SSc-ILD: treatment for ≥ 3 months with a stable dose for ≥ 4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study.

- Availability of skin for biopsy preferably on proximal forearms having Modified Rodnan Skin Score (mRSS) ≥2 at the biopsy location.

Inclusion Criteria for OLE Period:

- Completion of 52 weeks of treatment in the double-blinded treatment period.

- Investigator determination of a favorable benefit-risk for the individual participant, i.e., the expectation of reasonable likelihood for therapeutic benefit and tolerability of the study drug after evaluation of the preceding 52 weeks of double-blinded treatment.

Exclusion Criteria for all Participants:

- Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value.

- Known post-bronchodilator response in FEV1 and/or FVC (defined as an increase in percent predicted values by ≥ 10) - Resting oxygen saturation of <89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (5000 feet [1524 m] above sea level) during screening.

- History of lung transplant.

- Previous treatment with vixarelimab.

- Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening not successfully resolved by 4 weeks prior to screening visit.

- Presence of pulmonary hypertension requiring treatment.

- History of malignancy within the 5 years prior to screening.

- Positive hepatitis C virus (HCV) antibody test result accompanied by a positive HCV ribonucleic acid (RNA) test at screening.

- Known immunodeficiency.

- Known evidence of active or untreated latent tuberculosis.

Exclusion Criteria for Cohort 1:

- Evidence of other known causes of ILD.

- Emphysema present on ≥50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT.

Exclusion Criteria for Cohort 2:

- Evidence of other known causes of ILD.

- Rheumatic autoimmune disease other than SSc.

- Receiving pirfenidone treatment within 4 weeks prior to screening.

- Receipt of nintedanib in combination with tocilizumab.

Exclusion Criteria for OLE Period:

- Significant non-compliance in the double-blinded treatment period, per investigator's judgment.

- Any new clinically significant pulmonary disease other than IPF or SSc-ILD since enrolling in the double-blinded treatment period

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05785624
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Genentech, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Hungary, Israel, Italy, Mexico, New Zealand, Poland, South Africa, South Korea, Spain, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement

Arms & Interventions

Arms

Experimental: DBT: Cohort 1: Vixarelimab

Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.

Placebo Comparator: DBT: Cohort 1: Placebo

Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.

Experimental: DBT: Cohort 2: Vixarelimab

Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.

Placebo Comparator: DBT: Cohort 2: Placebo

Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.

Experimental: OLE Period: Cohort 1: Vixarelimab

Participants with IPF who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.

Experimental: OLE Period: Cohort 2: Vixarelimab

Participants with SSC-ILD who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.

Interventions

Drug: - Vixarelimab

Vixarelimab will be administered as per the schedule specified in the respective arms.

Drug: - Placebo

Placebo will be administered as per the schedule specified in the respective arms.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham 4049979, Alabama 4829764, 35233

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