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Study Protocol GB001, Inc. GB001 Protocol GB001-2101 Version 5.0, 16 Apr 2020 CLINICAL STUDY PROTOCOL Protocol Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi- Center Study to Evaluate the Effect of GB001 in Patients with Chronic Rhinosinusitis with or without Nasal Polyps Protocol Number: GB001-2101 Compound Number: GB001 Study Phase: Phase 2a Short Title: GB001 in Adult Subjects with Chronic Rhinosinusitis Sponsor Name: GB001, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. Legal Registered 3013 Science Park Road, Suite 200 Address: San Diego, CA 92121, USA Regulatory Agency Identifier Number: EudraCT: 2019-001682-33 Version: 5.0 Approval Date: 16 April 2020 Confidential This document contains proprietary and confidential information of GB001, Inc. Acceptance of this document constitutes agreement by the recipient that no previously unpublished information contained herein will be published or disclosed without the prior written approval of GB001, Inc. The following exceptions may occur under the condition that the party has agreed to keep this information confidential: 1) disclosure of information to the extent necessary to obtain informed consent, 2) disclosure of the document to study personnel under your supervision who need to know the contents for conducting the study, and 3) disclosure of the document to appropriate Institutional Review Boards (IRBs)/Independent Ethics Committees (IEC). The foregoing shall not apply to disclosure required by governmental regulations or laws; however, GB001, Inc. shall be promptly notified of any such disclosure. 1 CONFIDENTIAL GB001, Inc. GB001 Protocol GB001-2101 Version 5.0, 16 Apr 2020 SPONSOR’S AUTHORIZED REPRESENTATIVE SIGNATURE PAGE Gossamer Bio Services, Inc. on behalf of GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc. Medical Monitor name and contact information will be provided separately. 2 CONFIDENTIAL GB001, Inc. GB001 Protocol GB001-2101 Version 5.0, 16 Apr 2020 INVESTIGATOR AGREEMENT GB001-2101: A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of GB001 in patients with chronic rhinosinusitis with or without nasal polyps I, the undersigned, have read this protocol and agree to conduct this protocol in accordance with ethical principles as outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on Good Clinical Practice, any applicable laws and requirements and any additional conditions mandated by a regulatory authority and/or Institutional Review Board/Independent Ethics Committee (IRB/IEC). I acknowledge that I am responsible for the overall study conduct and I agree to personally conduct or supervise the described clinical study. I agree to ensure that the confidential information contained in this document will not be used for any purpose other than the evaluation or conduct of the clinical investigation without the prior written consent of GB001, Inc. Signature Name of Investigator Date 3 CONFIDENTIAL GB001, Inc. GB001 Protocol GB001-2101 Version 5.0, 16 Apr 2020 Section # and Name Description of Change Brief Rationale the risks to trial integrity during the COVID-19 pandemic Global Change Minor revisions to text Administrative clarifications were incorporated, and typographical errors were corrected 5 CONFIDENTIAL GB001, Inc. GB001 Protocol GB001-2101 Version 5.0, 16 Apr 2020 TABLE OF CONTENTS SPONSOR’S AUTHORIZED REPRESENTATIVE SIGNATURE PAGE ...................................2 INVESTIGATOR AGREEMENT...................................................................................................3 PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................4 1. PROTOCOL SUMMARY ..........................................................................................11 1.1. Synopsis ......................................................................................................................11 1.2. Schema ........................................................................................................................13 1.3. Schedule of Activities .................................................................................................14 2. INTRODUCTION ......................................................................................................18 2.1. Study Rationale ...........................................................................................................18 2.2. Background .................................................................................................................18 2.3. Benefit/Risk Assessment ............................................................................................19 2.3.1. GB001 Benefit/Risk Assessment ................................................................................19 2.3.2. Study Design Benefit/Risk Assessment ......................................................................20 3. OBJECTIVES AND ENDPOINTS ............................................................................21 4. STUDY DESIGN .......................................................................................................23 4.1. Overall Design ............................................................................................................23 4.1.1. Study Design ...............................................................................................................23 4.1.2. Unscheduled Visit .......................................................................................................24 4.2. Scientific Rationale for Study Design ........................................................................24 4.2.1. Study Population .........................................................................................................24 4.2.2. Choice of Control Group ............................................................................................25 4.2.3. Efficacy Endpoint Selection .......................................................................................25 4.3. Justification for Dose ..................................................................................................25 4.4. End of Study Definition ..............................................................................................25 5. STUDY POPULATION .............................................................................................26 5.1. Inclusion Criteria ........................................................................................................26 5.2. Exclusion Criteria .......................................................................................................26 5.3. Randomization Criteria ...............................................................................................29 5.4. Screen or Run-In Failures ...........................................................................................30 6. INVESTIGATIONAL PRODUCT ............................................................................30 6.1. Investigational Product Administered ........................................................................30 6 CONFIDENTIAL GB001, Inc. GB001 Protocol GB001-2101 Version 5.0, 16 Apr 2020 6.2. Preparation/Handling/Storage/Accountability ............................................................31 6.3. Randomization and Blinding ......................................................................................31 6.3.1. Randomization ............................................................................................................31 6.3.2. Assignment of Investigational Product Bottle Numbers ............................................31 6.3.3. Unblinding of an Individual Subject ...........................................................................31 6.4. Investigational Product Compliance ...........................................................................32 6.5. Concomitant Therapy .................................................................................................33 6.5.1. Prohibited and Restricted Medications Prior to the Screening Visit and Throughout the Study .................................................................................................33 6.6. Dose Modification ......................................................................................................33 6.7. Intervention After the End of the Study .....................................................................33 7. DISCONTINUATION OF INVESTIGATIONAL PRODUCT AND SUBJECT DISCONTINUATION/WITHDRAWAL ................................................33 7.1. Discontinuation of Investigational Product ................................................................33 7.1.1. Pregnancy ...................................................................................................................34 7.1.2. Liver Safety ................................................................................................................34 7.2. Subject Withdrawal from the Study ...........................................................................34 7.3. Lost to Follow-up .......................................................................................................35 8. STUDY ASSESSMENTS AND PROCEDURES ......................................................35 8.1. Efficacy Assessments .................................................................................................37
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