E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IDIOPATHIC PULMONARY FIBROSIS |
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E.1.1.1 | Medical condition in easily understood language |
IDIOPATHIC PULMONARY FIBROSIS |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To evaluate safety of lebrikizumab compared with placebo in patients with IPF
• To evaluate efficacy of lebrikizumab compared with placebo in patients with IPF, as measured by progression-free survival (PFS). |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the efficacy of lebrikizumab compared with placebo in patients with IPF on the basis of pulmonary function, diffusion capacity, death, non-elective hospitalization from any cause, and acute IPF exacerbations
• To evaluate the efficacy of lebrikizumab compared with placebo in patients with IPF on the basis of distance walked in 6 minutes and patient reported health-related quality of life.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult patient, >/= 40 years of age
- Have a definite IPF diagnosis according to the 2011 ATS/ARS/JRS/ALAT consensus statement on IPF within the previous 4 years from time of screening and confirmed at baseline
- Forced vital capacity (FVC) >/= 40% and </=90% predicted at screening
- Stable baseline lung function as evidenced by a difference of < 10% in FVC (L) measurements between screening and randomization
- Diffusion capacity of the lung for carbon monoxide >/= 25% and </= 90% predicted at screening
- Ability to walk >/= 100 meters unassisted in 6 minutes. |
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E.4 | Principal exclusion criteria |
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
- Evidence of other known causes of interstitial lung disease (ILD)
- Lung transplant expected within 12 months of screening
- Evidence of clinically significant lung disease other than IPF
- Post bronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.7 at screening
- Positive bronchodilator response, evidenced by an increase of >/= 12% predicted and 200 mL increase in FEV1 or FVC
- Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction < 35%
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
- Known current malignancy or current evaluation for potential malignancy
- Listeria monocytogenes infection or active parasitic infections within 6 months prior to randomization.
- Active tuberculosis requiring treatment within 12 months of screening
- Known immunodeficiency, including but not limited to HIV infection
- Past use of any anti-IL-13 or anti-IL-14/IL-13 therapy, including lebrikizumab
- Evidence of acute or chronic hepatitis or known liver cirrhosis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-free survival |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Change in pulmonary function (FVC, [L])
2. Change in diffusion capacity of the lung for carbon monoxide
3. Change in Quality of Life measurements
4. Time from randomization to death or non-elective hospitalization from any cause
5. Change in six minute walk test
6. Time from randomization to first event of acute IPF exacerbation
7. Safety: Incidence of adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. up to 2.5 years
2. from baseline to end of treatment (up to 2.5 years)
3. from baseline to Week 52
4. up to 2.5 years
5. from baseline to Week 52
6. up to 2.5 years
7. up to 2.5 years |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
France |
Germany |
Italy |
Japan |
Mexico |
Peru |
Poland |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |