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List of Completed Clinical Studies Based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS)

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List of Completed Clinical Studies Based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 1. Protocol IFN-K-002: “A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNα- Kinoid in Adult Subjects With Systemic Lupus Erythematosus” Research Sponsor: Neovacs Field of study: rheumatology Study Period: 2015 -2023 Principal Investigator: MD.Ph.D. Alikhanov B.A 2. Protocol Immune/BRT/UC-0: “A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis” Research Sponsor: Immune Pharmaceuticals Field of study: gastroenterology Study Period: 2017 -2018 Principal Investigator: MD.Ph.D. Alikhanov B.A 3. Protocol LTS11210( 0/ SARIL-RA-EXTEND): “A Randomized, Double-blind, Placebo- controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy” Research Sponsor: Sanofi Field of study: rheumatology Study Period: 2010 -2020 Principal Investigator: MD.Ph.D. Alikhanov B.A 4. Protocol MLN0002-3026/3027/3030 «A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab in Subjects With Ulcerative Colitis» Research Sponsor: Takeda 1 List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) Field of study: gastroenterology Study Period: 2016 -2020 Principal Investigator: MD.Ph.D. Alikhanov B.A 5. Protocol GA29144 / 45: “Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an indaction and maintenance treatment for patients with modererate to Severe Crohn`s Disease”. Research Sponsor: Hoffmann-La Roche Field of study: gastroenterology Study Period: 2017 -2018 Principal Investigator: MD.Ph.D. Alikhanov B.A 6. Protocol CT-P13 3.5: “A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active RA” Research Sponsor: Celltrion Field of study: rheumatology Study Period: 2017 -2019 Principal Investigator: MD.Ph.D. Alikhanov B.A 7. Protocol B7921005: “A 12 Week Randomized, Double-blind, Double Dummy, Parallel Group, Active And Placebo-controlled, Multicenter Study To Assess The Efficacy And Safety Profile Of Pf-06650833 In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate” Research Sponsor: PFIZER Field of study: rheumatology Study Period: 2017 -2019 Principal Investigator: MD.Ph.D. Alikhanov B.A 8. Protocol PCG-2\ 4-UCA (ICON 0479-0011): “Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on 2 List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine” Research Sponsor: Dr. Falk Pharma GmbH Field of study: gastroenterology Study Period: 2015 -2017 Principal Investigator: MD.Ph.D. Alikhanov B.A 9. Protocol RPC01-3101/3102: “A Phase 3, Multicenter, Randomized, Double-blind, Placebo- controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis” Research Sponsor: Celgene Field of study: gastroenterology Study Period: 2015 -2016 Principal Investigator: MD.Ph.D. Alikhanov B.A 10. Protocol CHS-0214-02: “A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate”. Research Sponsor: Coherus Biosciences, Inc. Field of study: rheumatology Study Period: 2014 -2015 Principal Investigator: MD.Ph.D. Alikhanov B.A 11. Protocol I1F-MC-RHBF: “A Phase 3, Multicenter Study with a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period from Week 36 to Week 104 to Evaluate the Long Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug–Naive Patients with Active Psoriatic Arthritis” Research Sponsor: Eli Lilly & Company Field of study: rheumatology Study Period: 2016 -2017 Principal Investigator: MD.Ph.D. Alikhanov B.A 3 List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 12. Protocol CBCT197A220: “An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation Research Sponsor: Novartis Pharmaceuticals” Field of study: pulmonology Study Period: 2011 -2013 Principal Investigator: MD.Ph.D. Alikhanov B.A 13. Protocol EFC11405: “A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of dronedarone 400mg BID in patients with permanent atrial fibrillation and additional risk factors. Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS)”. Research Sponsor: Sanofi Field of study: cardiology Study Period: 2010 -2012 Principal Investigator: MD.Ph.D. Alikhanov B.A 14. Protocol CNTO136 ARA3005: “A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis”. Research Sponsor: Janssen Research & Development, LLC Field of study: rheumatology Study Period: 2014 -2016 Principal Investigator: MD.Ph.D. Alikhanov B.A 15. Protocol P06241/P202;P04705: “A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)”. Research Sponsor: Merck Sharp & Dohme Corp. Field of study: pulmonology 4 List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) Study Period: 2014 -2015 Principal Investigator: MD.Ph.D. Alikhanov B.A 16. Protocol AI452-020: “A blind randomized comparative study of the use of telaprevir in addition to the combination of pegylated interferon lambda-1a with ribavirin or to the combination of pegylated interferon alpha-2a with ribavirin in patients with chronic hepatitis C 1 genotype who have not received treatment or who have relapsed after a previous course of treatment with pegylated interferon alpha and ribavirin. Phase III.” Research Sponsor:Bristol-Myers Squibb, USA, Phase:III Field of study: hepatology. Study Period: 2013 -2014 Principal Investigator: MD.Ph.D. Nikitin I.G. 17. Protocol AI447029: “Phase III open study of Asunaprevir and Daclatasvir plus Peginterferon Alfa-2a (Pegasis) and Ribavirin (Kopegus) (P / P) (quadrotherapy) in patients with genotypes 1 or 4 of chronic viral hepatitis C who are resistant / partially responding to treatment with Peginterferonalfa 2a or 2b plus Ribaverine.” Research Sponsor: Bristol-Myers Squibb, USA, Phase:III Field of study:hepatology. Study Period: 2012 -2013 Principal Investigator: MD.Ph.D. Nikitin I.G. 18. Protocol AI 452-017: “A randomized, double-blind, phase III study evaluating the efficacy and safety of Peginterferon Lambda-1a with and without daclatasvir compared to Peginterferon Alfa-2a, each in combination with Ribavirin, in patients with genotypes 2 or 3 of chronic viral hepatitis From previously not receiving treatment.” Research Sponsor:Bristol-Myers Squibb, USA, Phase:III Field of study: hepatology. Study Period: 2012 -2014 Principal Investigator: MD.Ph.D. Nikitin I.G. 19. Protocol CJ05013008: “The efficacy and safety of Narlaprevir, used in combination with Ritonavir in patients with chronic hepatitis C (genotype 1) who have not previously received 5 List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) treatment with pegylated interferon and ribavirin, or with the ineffectiveness of this prior therapy (PIONEER).” Research Sponsor:R-PHARM, Russia, Phase:III Field of study: hepatology. Study Period: 2014 -2016 Principal Investigator: MD.Ph.D. Nikitin I.G. 20. Protocol CLDT600A2409: “An open, randomized trial with a 104-week treatment period conducted to evaluate the efficacy and safety of telbivudine or tenofovir therapy in HBeAg- negative patients with chronic hepatitis B based on the roadmap concept.” Research Sponsor:Novartis, USA, Phase:III Field of study: hepatology. Study Period: 2011 -2015 Principal Investigator: MD.Ph.D. Nikitin I.G. 21. Protocol GS-US-334-0119: “A randomized, multicenter, phase 3b open-label study evaluating the safety and effectiveness of Sofosbuvir while prescribing previously untreated adult patients with chronic hepatitis C virus genotypes 1 and 3 with Ribavirin.” Research Sponsor:Gilead Sciences Inc, USA, Phase:III Field of study:hepatology. Study Period: 2013 -2014
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