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A Randomized, Double-Blind, Multi-Center, Parallel Group Study

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A Randomized, Double-Blind, Multi-Center, Parallel Group Study Revised Clinical Study Protocol Study Code PT010005 NCT # NCT02465567 Date: 21 JUNE 2019 A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD This submission /document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object. The following Amendment(s) are included in this revised protocol: Amendment No. Date of Amendment Version 1 18 MAY 2015 Version 2, Amendment 1 04 JULY 2015 Version 1.1 17 AUGUST 2015 Version 3, Amendment 4 08 JANUARY 2016 Version 4, Amendment 3 25 AUGUST 2016 Version 4.1 19 SEPTEMBER 2016 Version 5, Amendment 4 03 NOVEMBER 2017 Version 6, Amendment 5 27 MARCH 2018 Version 6.1 21 JUNE 2019 Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol Pearl Therapeutics, Inc. Clinical Study Protocol: PT010005-05 Version 6.1, 21 June 2019 CLINICAL STUDY PROTOCOL: PT010005-05 Study Title: A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD Study Number: PT010005-05 Study Phase: Phase III Product Name: Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI]) Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI) Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI) IND Number: 118313 EudraCT Number: 2014-005671-92 Indication: COPD Investigators: Multicenter Sponsor: Pearl Therapeutics, Inc. Sponsor Contact: Version Number Date Original Protocol Version 1.0 18 May 2015 Amended Protocol Version 2.0 04 July 2015 Amended Protocol Version 1.1 17 August 2015 Amended Protocol Version 3.0 08 January 2016 Amended Protocol Version 4.0 25 August 2016 Amended Protocol Version 4.1 19 September 2016 Amended Protocol Version 5.0 03 November 2017 Amended Protocol Version 6.0 27 March 2018 Amended Protocol Version 6.1 21 June 2019 Confidentiality Statement Property of Pearl Therapeutics, Inc. This document is confidential and may not be used, divulged, published, or otherwise disclosed without consent of Pearl Therapeutics, Inc. Confidential and Proprietary Page 1 of 194 Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol Pearl Therapeutics, Inc. Clinical Study Protocol: PT010005-05 Version 6.1, 21 June 2019 SUMMARY OF CHANGES FROM VERSION 6.0 INCLUDED IN THIS PROTOCOL AMENDMENT VERSION 6.1 Sections(s)/Description of Change Rationale Synopsis, Section 2.2 This is to cover additional COPD- Added secondary objective: to assess the exacerbation-related endpoints not effect of BGF MDI relative to GFF MDI and covered by the primary objective. BFF MDI on COPD exacerbations. Synopsis, Sections 3.1.2, 3.1.3, and 9.4.3.7 Severe exacerbations are highly Rate of severe COPD exacerbations is now a clinically relevant and are a predictor secondary efficacy endpoint instead of an of mortality “other” efficacy endpoint. Synopsis, Sections 3.1.3, 3.3.1, 9.4.3.3, In our previous studies, these 9.4.3.5, 9.4.3.6, 9.4.4.1, 9.4.4.2, and 9.4.4.5 endpoints did not provide further Removed analysis of the following other insights into the primary and endpoints out of Protocol: secondary endpoints and were consequently not discussed in the x Compliance for EQ 5D CSR. Furthermore, removal of these x Change from baseline in morning pre endpoints will reduce the volume of dose trough, AUC04, and peak change output for the CSR and facilitate from baseline in forced vital capacity focused review. (FVC), peak expiratory flow rate (PEFR), and forced expiratory flow between 25% and 75% of FVC (FEF25 75). x Individual components of the TDI: functional impairment, magnitude of task, and magnitude of effort over 24 weeks, over 52 weeks, and at each post randomization visit x Individual domains of the SGRQ: Symptoms, Activity, and Impacts over 24 weeks, over 52 weeks, and at each post randomization visit x EXACT symptom domain scores for breathlessness, cough and sputum, and chest symptoms over 24 weeks, over 52 weeks and over each 4-week Confidential and Proprietary Page 2 of 194 Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol Pearl Therapeutics, Inc. Clinical Study Protocol: PT010005-05 Version 6.1, 21 June 2019 Sections(s)/Description of Change Rationale interval of the 52 week treatment period x Rate and time to first COPD exacerbation treated with systemic steroids x Rate and time to first COPD exacerbation treated with antibiotics Synopsis, Section 3.3.2.2 This is to reflect previous Holter study For 24-hour Holter monitoring sub-study endpoints from similar studies. endpoints, added the following endpoints: x Change from baseline in the frequency of supraventricular ectopic beats x Incidence of withdrawal criteria being met during 24-hour Holter monitoring Added the “isolated” for the following endpoints: x Change from baseline in the frequency of isolated ventricular ectopic events (including a single premature ventricular contraction [PVC]) x Change from baseline in the frequency of isolated supraventricular ectopic events Removed the following endpoint: x Incidence of sustained ventricular tachycardia (SVT) [defined as PVCs lasting>30 seconds] Section 3.4 The addition of “due to COPD” is for clarification purpose. The reason for addition of “Calls to any health-care provider” is to cover all types of visits for the analysis. Confidential and Proprietary Page 3 of 194 Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol Pearl Therapeutics, Inc. Clinical Study Protocol: PT010005-05 Version 6.1, 21 June 2019 Sections(s)/Description of Change Rationale For health care resource utilization endpoints, added “due to COPD” for the endpoint “The number of days missed work”. Added “Calls to any health-care provider” for the following endpoints: x The percentage of subjects with telephone calls to health care providers x The mean number of telephone calls to health care providers x The percentage of subjects with visits to health care providers x The mean number of visits to health care providers Section 9.4.2.1 Avoid the exclusion of meaningful Updated the definition for the duration of COPD exacerbation records from the moderate or severe COPD exacerbations. A analysis CRF-recorded COPD exacerbation resulting in a hospitalization or death will be considered as a countable moderate to severe (and also severe) COPD exacerbation regardless of whether systemic corticosteroids or systemic antibiotics were used to treat the exacerbation. Section 9.4.2.1 Provide a clarification for the Clarified that the start day of a COPD calculation exacerbation will not be excluded from the time-at-risk of a COPD exacerbation. Synopsis, Sections 9.4.2.1, 9.4.3.1, 9.4.3.3, Eosinophil counts are skewed to the 9.4.3.4, 9.4.3.5, 9.4.4.4, 9.4.5.1, and 9.4.5.2 right and transformation reduces the Updated analyses to include the log baseline influence of a few outlying high blood eosinophil count as a covariate instead values. of baseline blood eosinophil count. Sections 9.4.5.2, and 9.4.5.3 This analysis model was incompletely For FEV1 AUC 0-4, it is clarified that this is stated before as an ANCOVA without a linear mixed repeated measures (RM) reference to RM. ANCOVA analysis (which is the analysis type also being used for pre-dose trough FEV1) instead of ANCOVA. Confidential and Proprietary Page 4 of 194 Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol Pearl Therapeutics, Inc. Clinical Study Protocol: PT010005-05 Version 6.1, 21 June 2019 Sections(s)/Description of Change Rationale Section 9.4.5.4 These terms were inadvertently For rate of decline in pre-dose FEV1 and omitted in the previous version of FEV1 AUC0-4, added treatment and smoking protocol. status at screening as categorical covariates, and added the interaction between screening smoking status and time and the interaction between baseline FEV1 and time in the model. Section 9.4.6 This NI margin was incorrect in the The non-inferiority (NI) margin was updated prior version of the protocol from 0.1 to 1.1 for the comparisons of BGF MDI 160/14.4/9.6 g to BFF MDI 320/9.6 g on COPD exacerbations. Section 9.4.8 This was done to align with revised Criteria for upper limit for Glucose were safety thresholds based on medical changed for potentially clinically significant history. laboratory values. Other administrative changes to correct and/or clarify protocol language were also addressed. These changes included edits for consistency, grammar, and typographical errors, which are not summarized in this table. Confidential and Proprietary Page 5 of 194 Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol Pearl Therapeutics, Inc. Clinical Study Protocol: PT010005-05 Version 6.1, 21 June 2019 SYNOPSIS Sponsor: Pearl Therapeutics, Inc. (“Pearl”) Name of Finished Product: Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI]) Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI) Budesonide and Formoterol fumarate Inhalation Aerosol (PT009, BFF MDI) Name of Active Ingredients: Budesonide, Glycopyrronium, and Formoterol Fumarate Glycopyrronium and Formoterol Fumarate Budesonide and Formoterol
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