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CJM112 a Randomized, Subject and Investigator Blinded, Placebo

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CJM112 a Randomized, Subject and Investigator Blinded, Placebo Novartis Institutes for BioMedical Research CJM112 Clinical Trial Protocol CCJM112X2203 A randomized, subject and investigator blinded, placebo-controlled, multi-center study in parallel groups to assess the efficacy and safety of CJM112 in patients with moderate to severe inflammatory acne Document type: Amended Protocol Version EUDRACT number: 2016-002492-95 Version number: v02 (Clean) Clinical Trial Phase: II Release date: 14-Dec-2016 Property of Novartis Confidential May not be used, divulged, published, or otherwise disclosed without the consent of Novartis Novartis Confidential Page 2 Amended Protocol Version v02 (Clean) Protocol No. CCJM112X2203 Site Operations Manual (SOM) A Site Operations Manual (SOM) accompanies this protocol, providing the operational details for study conduct. Note: The SOM will not be part of the Clinical Study Report. Notification of serious adverse events Dear Investigator, You must report a Serious Adverse Event (SAE) (initial or follow-up) to Novartis as summarized below. Refer to Section 9.2 of the protocol for SAE criteria and additional requirements. See also page 2 of the SOM for further details on the method of reporting a SAE. Complete SAE report Submit SAE report to Novartis Drug Safety and Epidemiology (DS&E) within 24 hours after awareness of the SAE Notify the Novartis Medical Lead The fax number(s) and email address(es) are located in the SOM. Novartis Confidential Page 3 Amended Protocol Version v02 (Clean) Protocol No. CCJM112X2203 Table of contents Site Operations Manual (SOM)...........................................................................................2 Notification of serious adverse events.................................................................................2 Table of contents .................................................................................................................3 List of tables ........................................................................................................................7 List of figures ......................................................................................................................7 List of abbreviations ............................................................................................................8 Pharmacokinetic definitions and symbols .........................................................................12 Glossary of terms...............................................................................................................13 Corporate Confidential Information Protocol synopsis...............................................................................................................21 1 Introduction .......................................................................................................................25 1.1 Background............................................................................................................25 Corporate Confidential Information 1.4 Study purpose ........................................................................................................31 2 Study objectives and endpoints .........................................................................................31 2.1 Primary objective...................................................................................................31 2.2 Secondary objective(s)...........................................................................................31 Corporate Confidential Information 3 Investigational plan ...........................................................................................................33 3.1 Study design...........................................................................................................33 3.2 Rationale of study design.......................................................................................34 3.3 Rationale for dose/regimen, route of administration and duration of treatment....37 3.4 Rationale for choice of comparator .......................................................................38 3.5 Rationale for choice of background therapy..........................................................39 Corporate Confidential Information 3.7 Risks and benefits..................................................................................................39 3.7.1 Blood sample volumes ..........................................................................41 4 Population..........................................................................................................................43 4.1 Inclusion criteria ....................................................................................................43 Novartis Confidential Page 4 Amended Protocol Version v02 (Clean) Protocol No. CCJM112X2203 4.2 Exclusion criteria...................................................................................................43 5 Restrictions for Study Subjects .........................................................................................46 5.1 Contraception requirements...................................................................................46 5.2 Prohibited treatment...............................................................................................47 5.3 Dietary restrictions and smoking...........................................................................48 5.4 Other restrictions ...................................................................................................48 6 Treatment...........................................................................................................................49 6.1 Study treatment......................................................................................................49 6.1.1 Investigational treatment and placebo...................................................49 6.1.2 Additional study treatment....................................................................49 6.2 Treatment arms ......................................................................................................49 6.3 Treatment assignment and randomization .............................................................50 6.4 Treatment blinding.................................................................................................51 6.5 Treating the subject................................................................................................52 6.6 Permitted dose adjustments and interruptions of study treatment .........................52 6.7 Emergency breaking of assigned treatment code ..................................................52 6.8 Treatment exposure and compliance .....................................................................53 6.9 Recommended treatment of adverse events ..........................................................53 6.10 Rescue medication.................................................................................................53 6.11 Concomitant treatment...........................................................................................53 7 Study completion and discontinuation ..............................................................................54 7.1 Study completion and post-study treatment ..........................................................54 7.2 Discontinuation of study treatment........................................................................54 7.3 Withdrawal of informed consent ...........................................................................55 7.4 Lost to follow-up ...................................................................................................55 7.5 Study stopping rules ..............................................................................................55 7.6 Early study termination by the sponsor .................................................................56 8 Procedures and assessments ..............................................................................................57 8.1 Informed consent procedures.................................................................................60 8.2 Subject screening...................................................................................................60 8.3 Subject demographics/other baseline characteristics.............................................61 8.4 Efficacy / Pharmacodynamics ...............................................................................61 8.4.1 Clinical Outcome Assessments (COAs) ...............................................61 Corporate Confidential Information 8.5 Safety .....................................................................................................................67 8.5.1 Physical examination ............................................................................67 8.5.2 Vital signs..............................................................................................67 Novartis Confidential Page 5 Amended Protocol Version v02 (Clean) Protocol No. CCJM112X2203 8.5.3 Height and weight .................................................................................67 8.5.4 Laboratory evaluations..........................................................................68 8.5.5 Electrocardiogram (ECG) .....................................................................68 8.5.6 Pregnancy and assessments of fertility .................................................69 8.5.7 Tuberculosis test....................................................................................69
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