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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514246-37-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 (Part A) of 2 doses of CHF10067 (zampilimab), with an optional 24-week double-blind, placebo-controlled extension phase (Part B) in participants with idiopathic pulmonary fibrosis.
It is a phase IIb, multicentre, randomised, double-blind, placebo-controlled, three-arm parallel-group study.
A total of 240 participants with IPF (Idiomatic Pulmonary Fibrosis) will be randomised in approximately 150 investigational sites in North and Latin America, Europe, Asia, and Oceania. The optional extension phase (Part B) is only applicable to the European Union and Macedonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm A | Experimental | CHF10067 (Test Dose 1) |
|
| Treatment arm B | Experimental | CHF10067 (Test Dose 2) |
|
| Treatment arm C | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF10067 | Drug | Dose 1 CHF10067 Intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure:Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30 | Weeks 6, 12, 18, and 30 | |
| Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 | Weeks 6, 12, 18, and 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiesi Clinical Trial Info | Contact | + 39 0521 2791 | Clinicaltrials_info@chiesi.com |
| Name | Affiliation | Role |
|---|---|---|
| Vincent COTTIN | Louis Pradel Hospital - Lyon, FRANCE | Principal Investigator |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Part A (Main study phase) of the study will include a screening period of 6 weeks (including prescreening), a treatment period of 21 weeks (with evaluation of primary variable at Week 24), and a follow-up period of 9 weeks after the last dose or the discontinuation of study treatment.
The 9 week follow-up period is applicable for participants not enrolled in the optional extension study phase.
Optional Part B (extension study phase) of the study will include a treatment period of 21 weeks, and a follow-up period of 9 weeks after the last dose or the discontinuation of study treatment.
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The Investigational Medicinal Product (IMP) is blinded for the participant, investigators, and the sponsor. At the study site an unblinded pharmacist (or designee) will prepare the IMP and an unblinded clinical research associate will check the IMP related documentation Unblinded Sponsor and Clinical Research organization's Study Managers and Clinical Supplies representative will be also assigned.
| CHF10067 |
| Drug |
Dose 2 CHF10067 Intravenous infusion |
|
| Placebo | Other | Placebo Intravenous infusion |
|
| Categorical absolute change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%) | Weeks 6, 12, 18, and 30 |
| Categorical relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%) | Week 24 and at Weeks 6, 12, 18 |
| Rate of decline in ppFVC over 24 weeks | over 24 weeks |
| Absolute and relative change from baseline in FVC (forced vital capacity)(mL) at Week 24 and at Weeks 6, 12, 18, and 30 | Week 24 and at Weeks 6, 12, 18 and 30 |
| Categorical absolute change from baseline in FVC (mL) at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -200 mL, -100 mL, 0 mL, 100 mL, and 200 mL) | Week 24 and at Weeks 6, 12, 18, and 30 |
| Rate of decline in FVC (mL) over 24 weeks | over 24 Weeks |
| Change from baseline in the L-PF(Living with Pulmonary Fibrosis) questionnaire at Week 12 and at Week, 24 | at Week12 and at Week 24 |
| Change from baseline in specific modules of the L-PF questionnaire (symptoms and impact) and within the symptom modules of specific domains (shortness of breath, cough, and fatigue) at Week 12 and at Week 24 | W12 and at Week 24 |
| CHF10067 concentrations at each visit (Week 0 to Week 21) | Over 21 Weeks |