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Version 1.0 + Amnd 1.0 Clinical Trial Protocol + Amnd 2.0, 3.0 + 4.0 AIC316-01-II-02 May 02, 2013 CLINICAL TRIAL PROTOCOL A double-blind, double dummy, randomized cross-over trial to compare the effect of AIC316 100 mg once daily versus valacyclovir 500 mg once daily on genital HSV shedding in HSV-2 seropositive adults. Trial No./Trial Identification Code: AIC316-01-II-02 Sponsor AiCuris GmbH & Co. KG Friedrich-Ebert-Str. 475 / Building 302 42117 Wuppertal Germany Sponsor Contact Burkhard Timmler, MD Medical Director AiCuris GmbH & Co. KG Friedrich-Ebert-Str. 475 / Building 302 42117 Wuppertal Germany Phone: +49 202 31763 FAX: +49 202 31763 Contract Research Organization Clinical Phase 2 Version Final 1.0 + Amendment 1.0 (September 24, 2012) + Amendment 2.0 (October 17, 2012) + Amendment 3.0 (December 18, 2012) + Amendment 4.0 (May 02, 2013) Date of Protocol July 05, 2012 Amendment 4.0 (May 02, 2013) This document is strictly confidential. Disclosure of contents or any trial-related information to third parties other than applicable IEC(s)/IRB(s) and regulatory authorities is not permitted except by written consent of AiCuris GmbH & Co. KG. CONFIDENTIAL page 1 of 125 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Version 1.0 + Amnd 1.0 Clinical Trial Protocol + Amnd 2.0, 3.0 + 4.0 AIC316-01-II-02 May 02, 2013 1.2 Declaration by the Principal Investigator I have read this protocol and agree that it contains all the necessary details for carrying out this trial. I agree to personally conduct or supervise the trial-related activities at my investigative site as described in this protocol and will complete the trial-related activities for all enrolled subjects within the time designated for the trial. I verify that I am suitably qualified by my education, scientific medical training and experience to conduct the trial. Documentation of my qualifications and professional affiliations are contained in my signed and dated current curriculum vitae. I will provide the supplied copies of the protocol and all information relating to non-clinical and prior clinical experience (e.g., Investigator’s Brochure [IB]) to all staff in my unit who participates in this trial. I will discuss this material with them to ensure that they are fully conversant with the medical treatment in, and the conduct of, the trial, and that they will handle the data and information generated in the trial confidentially. I agree not to start enrolling subjects until a duly appointed Ethics Committee (EC)/Institutional Review Board (IRB) has issued a favorable opinion and the Competent Authorities (CA) have approved the trial. I will conduct the trial in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, and the moral, ethical and scientific principles that justify medical research. The trial will be conducted in accordance with the relevant laws and regulations relating to clinical trials and the protection of subjects in the country in which I will perform the trial. All subjects will be comprehensively informed about the nature of the trial, of its investigational nature and that they may withdraw from the trial at any time. They will give their written consent to participate before entry into the trial. I will only use the subject information sheet and informed consent form approved by AiCuris GmbH & Co. KG and the EC/IRB which has reviewed this trial. I will supply AiCuris GmbH & Co. KG any material written by myself (e.g., summary of trial, correspondence, etc.) which has been given to the EC/IRB in support of the application. I have read the current version of the IB, including the potential risks (especially the results of the pharmacological and toxicological examination) and adverse drug effects of the investigational medicinal product obtained in previous clinical trials and I agree to report all adverse events (AEs) that occur during the trial. Where applicable, the information contained in the electronic case report forms (eCRFs) will be transcribed from my records, reports and manuscripts. The eCRF may be the original source for certain items. Either I, or an appointed person, will attest to the authenticity of the data and accuracy and completeness of the transcriptions by providing an electronic signature in the eCRF. I agree to the audit and monitoring procedures described in the protocol which involve verification of trial records against the original records. I will make available additional background data from my records at the request of government regulatory agencies, if allowed by the hospital or institution where the trial is being conducted. I am aware of the requirements for the correct reporting of serious AEs, and I undertake to document and to report such events as requested. I understand that I am obliged to provide the complete results and all data generated during the trial to AiCuris GmbH & Co. KG for their unrestricted use. I understand and agree that such trial results, data, CONFIDENTIAL page 3 of 125 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Version 1.0 + Amnd 1.0 Clinical Trial Protocol + Amnd 2.0, 3.0 + 4.0 AIC316-01-II-02 May 02, 2013 and all information concerning the investigational medicinal product(s) and AiCuris GmbH & Co. KG’s activities, such as patents, formulae, manufacturing procedures and basic, unpublished scientific data and information supplied by AiCuris GmbH & Co. KG or generated during the trial are confidential, and are the exclusive property of AiCuris GmbH & Co. KG. I undertake only to use this information plus the investigational medicinal product to conduct the trial and not to use it for any other purpose without the written agreement of AiCuris GmbH & Co. KG. I will supply AiCuris GmbH & Co. KG with the trial data in such a way that the subjects cannot be personally identified. As the Principal Investigator I will also adhere to the given detailed investigator responsibilities as specified in Appendix 20.1 of this protocol. Investigator Signature date Name and Address* Telephone number* * If the address or phone number of the Investigator changes during the course of the trial, written notification will be provided by the Investigator to the AiCuris GmbH & Co. KG and Inc. This will not require protocol amendment(s). CONFIDENTIAL page 4 of 125 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Version 1.0 + Amnd 1.0 Clinical Trial Protocol + Amnd 2.0, 3.0 + 4.0 AIC316-01-II-02 May 02, 2013 1.3 Involved Parties 1. Sponsor’s Medical Burkhard Timmler, MD Director AiCuris GmbH & Co. KG Friedrich-Ebert-Straße 475 / Building 302 42117 Wuppertal, Germany Office phone: +49 (0) 202 31763 Office fax: +49 (0) 202 31763 Email: 2. Coordinating Investigator Anna Wald, MD, MPH University of Washington Virology Research Clinic 908 Jefferson St, Suite 11NJ-1166, Seattle, WA 98104, USA Office phone: Office fax: 3. Sponsor’s Clinical Trial Christiane Vank, PhD Manager AiCuris GmbH & Co. KG Friedrich-Ebert-Straße 475 42117 Wuppertal, Germany Office phone: 49 202 31763 Office fax: 49 202 31763 Email: 4. CRO’s Clinical Trial Manager : 5. Statistical analysis CONFIDENTIAL page 5 of 125 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Version 1.0 + Amnd 1.0 Clinical Trial Protocol + Amnd 2.0, 3.0 + 4.0 AIC316-01-II-02 May 02, 2013 6. Sponsor’s Dirk Kropeit, MD Pharmacokineticist AiCuris GmbH & Co. KG Friedrich-Ebert-Straße 475 42117 Wuppertal, Germany Office phone: 49 202 31763 Office fax: 49 202 31763 Email: 7. Bioanalysis of pharmacokinetic samples and samples for evaluation of potential drug metabolites 8. Analysis of routine blood and urine samples 9. Pharmacovigilance (SAE reporting) 10. HSV Western Blot, Anne Cent University of Washington, Virology Laboratory Children’s Hospital & Medical Center Room W8814 4800 Sand Point Way N. E. Seattle, WA 98105, USA Office phone: Email: CONFIDENTIAL page 6 of 125 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Version 1.0 + Amnd 1.0 Clinical Trial Protocol + Amnd 2.0, 3.0 + 4.0 AIC316-01-II-02 May 02, 2013 11. HSV DNA PCR, Meei-Li Huang Sequencing University of Washington Molecular Diagnostic Laboratory 1616 Eastlake Ave E, Suite 320 Seattle, WA 98102, USA Office Phone: E-Mail: 12. Preparation and supply of Trial medication kits 13. Pharmacogenetic analysis CONFIDENTIAL page 7 of 125 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Version 1.0 + Amnd 1.0 Clinical Trial Protocol + Amnd 2.0, 3.0 + 4.0 AIC316-01-II-02 May 02, 2013 2 PROTOCOL SYNOPSIS Trial No. AIC-316-01-II-02 Title A double-blind, double dummy, randomized cross-over trial to compare the effect of AIC316 100 mg once daily versus valacyclovir 500 mg once daily on genital HSV shedding in HSV-2 seropositive adults. Trial Identification AIC-316-01-II-02 Code Clinical Phase 2 Trial design Approximately ninety subjects with proven recurrent episodes of genital herpes will be randomized to receive an oral daily dose of either AIC316 100 mg or valacyclovir 500 mg for 28 days, then to undergo a 4 week washout period, followed by a second 28 day period receiving the corresponding other treatment (cross over design), and ending with a 28 day follow up period. Appropriate matching placebo will be administered in parallel to the verum. During both, the first and second treatment period, subjects will obtain swabs of the genital secretions 4 times a day and maintain a diary of genital signs and symptoms.
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