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Study Protocol); Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 CLINICAL PROTOCOL A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE Compound: PF-04383119 Compound Name: Tanezumab United States (US) Investigational New BB-IND 11,680 Drug (IND) Number: European Clinical Trial Database 2012-003721-22 ) (EudraCT) Number: Protocol Number: A4091058 GMT ( Phase: 3 This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold this information in confidence and not copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified. roved On: 06-Jun-2016 11:33 pp roved\A pp 090177e191ffa88c\Approved\Approved On: 03-Oct-2019 14:27 (GMT) 090177e1883c9873\A PFIZER CONFIDENTIAL Page 1 Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 Document History Document Version Date Summary of Changes and Rationale Amendment 2 15 May 2016 Inclusion criterion #4 and associated text throughout the protocol has been updated to expand the number of pre-study, non-steroidal anti-inflammatory drug (NSAID) osteoarthritis pain treatment regimens that are considered to be qualifying. The following pre- study NSAID treatment regimens are now considered to be qualifying for prospective study subjects: Ibuprofen 1200 – 3200 mg/day Loxoprofen 120 – 180 mg/day Meloxicam 5 - 15 mg/day Nabumetone 1000 – 2000 mg/day ) Aceclofenac 200 mg/day GMT ( Sulindac 200 – 400 mg/day Ketoprofen 200 mg/day To account for formulations of naproxen that include the sodium salt of naproxen, the lowest qualifying dose of naproxen is set at 440 mg/day. Exclusion criterion #21 has been updated to provide additional clarity regarding exclusion of subjects who have a history of heart block. Randomization criterion #9 and associated text in roved On: 06-Jun-2016 11:33 protocol Section 6.1.1 (Screening procedures) has pp been updated to provide a provision for re-selection of an index joint if the initially selected index joint does not have a qualifying Kellgren-Lawrence grade. roved\A pp Administrative updates in the Protocol Summary, Section 3, Section 5.8.2, Section 6.1.4 and 7.4.4 to: • Provide flexibility in the length of the Initial Pain Assessment Period (minimum of 3 days). • Provide clarification that the cost of standard 090177e191ffa88c\Approved\Approved On: 03-Oct-2019 14:27 (GMT) 090177e1883c9873\A PFIZER CONFIDENTIAL Page 2 Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 of care medication that subjects can receive 16 weeks after the last dose of subcutaneous study medication will be reimbursed by the sponsor if allowed per local regulation. • Provide clarification of the intended follow- up for subjects with severe and persistent joint pain. Amendment 1 10 July 2015 Changes made in response to United States Food and Drug Administration Advice/Information Request (30 June 2015): • Inclusion criterion pertaining to inclusion of subject population with a prior history of failure, intolerance or unwillingness to take approved standard of care therapies for osteoarthritis pain has been added (Inclusion # 4). ) • Minor revisions in Protocol Summary, and GMT protocol Sections 1.2.5, 3 have been updated ( to harmonize pre-study NSAID regimen text with updates in exclusion criterion 4 (noted above). • Protocol Sections 6.1 and 6.1.1 have been updated to reflect the required level of evidence to establish that subjects meet the updated inclusion criterion pertaining to inclusion of a subject population with a prior history of failure, intolerance or unwillingness to take approved standard of care therapies for roved On: 06-Jun-2016 11:33 osteoarthritis pain. pp • Required washout from rescue medication (acetaminophen / paracetamol) use before roved\A clinic visits has been decreased from 48 to pp 24 hours where applicable throughout the protocol. The Single Reference Safety Documents cited in Protocol Section 1.2.5 have been updated and relevant text in Section 5.6 has been harmonized with this update. 090177e191ffa88c\Approved\Approved On: 03-Oct-2019 14:27 (GMT) 090177e1883c9873\A PFIZER CONFIDENTIAL Page 3 Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 Definitions for completion of treatment and completion of study have been clarified in Protocol Section 3. Text pertaining to analysis of actigraphy data in Section 9.4.4.2 has been revised. Specific physical activity intensity thresholds have been removed from the protocol and will be available in the statistical analysis plan. Administrative changes (instructional text pertaining to archiving of completed PHQ-9 questionnaires in subject source documents and updates for consistency with Pfizer Protocol Template version 16 Feb 2015). Original protocol 01 April 2015 Not Applicable (N/A) This amendment incorporates all revisions to date, including amendments made at the ) request of country health authorities, institutional review boards/ethics committees (IRBs/ECs), etc. GMT ( roved On: 06-Jun-2016 11:33 pp roved\A pp 090177e191ffa88c\Approved\Approved On: 03-Oct-2019 14:27 (GMT) 090177e1883c9873\A PFIZER CONFIDENTIAL Page 4 Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 PROTOCOL SUMMARY Background Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions. The completed Phase 2 and Phase 3 studies conducted to date have demonstrated that tanezumab is efficacious and generally safe and well tolerated for the treatment of pain due to osteoarthritis and chronic low back pain. In addition, completed Phase 1/2 studies suggest tanezumab is also efficacious and generally safe for the treatment of neuropathic, visceral, and cancer pain. In 2010, the US Food and Drug Administration’s (FDA) Division of Analgesia, Anesthetic, and Addiction Products (DAAAP) placed tanezumab (June/July 2010) and subsequently the entire NGFI class (December 2010) on partial clinical hold due to adverse events initially described by investigators as osteonecrosis that in some cases resulted in total joint replacement. Pfizer voluntarily imposed the partial clinical hold on study conduct in all ) countries. GMT ( Extensive analyses of the reports of osteonecrosis and other total joint replacements were conducted.1 On March 12, 2012, the FDA Arthritis Advisory Committee reviewed these results as well as those prepared by the FDA.2,3 The committee endorsed continued clinical development of the NGFI class of compounds with additional measures to minimize the risk and further protect subject safety. On August 28, 2012, the FDA lifted the partial clinical hold on tanezumab allowing the resumption of clinical studies for osteoarthritis and all other chronic pain conditions. Using recommendations from discussions with European agencies [United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Germany’s Paul Ehrlich Institute (PEI) and Spain’s Agency on Medicinal Products and Medical Devices (AEMPS)] as well as the FDA Arthritis Advisory Committee and interactions with FDA, risk mitigation roved On: 06-Jun-2016 11:33 measures were developed and are incorporated in the design and objectives of the current pp study. The FDA placed another partial clinical hold on the tanezumab clinical development program roved\A as well as all anti-NGF antibody studies in 2012 due to concerns about adverse changes in pp the sympathetic nervous system of mature animals. Only studies in patients with cancer pain were allowed to continue. In animal studies in rats and non-human primates, tanezumab treatment for up to 6 months, with doses producing greater systemic exposure than observed with clinical doses, was associated with lower sympathetic ganglion volume and lower average size of post-ganglionic sympathetic neurons when compared to control animals. All effects were completely reversible following a dosing-free recovery period. In a separate cardiovascular 090177e191ffa88c\Approved\Approved On: 03-Oct-2019 14:27 (GMT) 090177e1883c9873\A PFIZER CONFIDENTIAL Page 5 Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 function study in non-human primates, functional changes in the cardiovascular system controlled by the sympathetic nervous system were not observed. Although evidence of clinically important effects on the sympathetic nervous system have not been identified in previously completed tanezumab studies, per agreement with the FDA, this and other clinical studies of tanezumab will incorporate additional safety measures to monitor for and manage subjects who may develop evidence of clinically important sympathetic nervous system dysfunction. The primary objectives of this study are: 1) to characterize the long-term joint safety risks of tanezumab using a composite endpoint (includes adjudication outcomes of rapidly progressive osteoarthritis (type-1 and type-2), subchondral insufficiency fracture (or SPONK), primary osteonecrosis, or pathological fracture and 2) demonstrate the analgesic superiority of tanezumab relative to non-steroidal
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