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

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

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

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

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

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 Principal Investigator: MD.Ph.D. Nikitin I.G.

22. Protocol GS-US-337-1463: “Phase 3b open-label study to evaluate the safety and efficacy of the combination of ledipasvir / sofosbuvir in adult patients with chronic hepatitis C virus infection.” Research Sponsor:Gilead Sciences Inc, USA, Phase:III Field of study:hepatology. Study Period: 2015 -2016 Principal Investigator: MD.Ph.D. Nikitin I.G.

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 23. Protocol MK-3682B-037: “Clinical Phase III study to evaluate the efficacy and safety of a combination regimen of MK-3682B (Grazoprevir / Grazoprevir / Ruzasvir / Uprifosbuvir) in patients with genotype 3 chronic viral hepatitis C.” Research Sponsor:Merk&Co., INC., USA, Phase:III Field of study: hepatology. Study Period: 2017 Principal Investigator: MD.Ph.D. Nikitin I.G.

24. Protocol MK5172-017: “A long-term follow-up study to evaluate the duration of a virological response and / or the nature of viral resistance in patients with chronic viral hepatitis C who received MK-5172 in a previous clinical trial.” Research Sponsor:Merk&Co., INC., USA, Phase:III Field of study: hepatology. Study Period: 2016 -2017 Principal Investigator: MD.Ph.D. Nikitin I.G.

25. Protocol MK5172-067: “A randomized international clinical trial of phase III of the efficacy and safety of the MK-5172 / MK-8742 combination therapy regimen in previously untreated patients with chronic hepatitis C infected with the virus of genotypes 1, 4 and 6”. Research Sponsor:Merk&Co., INC., USA, Phase:III Field of study: hepatology. Study Period: 2015-2016 Principal Investigator: MD.Ph.D. Nikitin I.G.

26. Protocol P07755 (MK-3034-040): “A study of the 3 phases of safety and efficacy of boceprevir in combination with pegylated interferon alpha-2a and ribavirin in patients with chronic hepatitis C infected with 1 virus genotype, CC genotype IL28B.” Research Sponsor:Merk&Co., INC., USA, Phase:III Field of study: hepatology. Study Period: 2012 - 2013 Principal Investigator: MD.Ph.D. Nikitin I.G.

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 27. Protocol P018160: “A study of the safety and efficacy of use of boceprevir in the Russian population in combination with pegylated interferon alpha-2b and ribavirin in patients with chronic hepatitis C infected with 1 genotype of the virus who have not received previous antiviral therapy, as well as in patients with ineffectiveness of the previous course of antiviral therapy pegylated interferon and ribavirin.” Research Sponsor:Merk&Co., INC., USA, Phase:III Field of study: hepatology. Study Period: 2011 - 2013 Principal Investigator: MD.Ph.D. Nikitin I.G.

28. Protocol VX - 950HEP3002: “A multicenter, open-label program for providing early access to telaprevir in combination with pegylated interferon alfa and ribavirin for patients with chronic viral hepatitis C, type I genotype, in the presence of severe fibrosis and compensated cirrhosis.” Research Sponsor:Vertex Pharmaceuticals, INC., USA, Phase:IV Field of study:hepatology. Study Period: 2012 - 2013 Principal Investigator: MD.Ph.D. Nikitin I.G.

29. Protocol VX - 950HPC3007: “An open supporting study conducted in Russia to determine the efficacy and safety of Telaprevir, pegylated interferon - alpha2a and Ribavirin in patients with chronic hepatitis C genotype 1 - previously treated or not treated.” Research Sponsor:Vertex Pharmaceuticals, INC., USA, Phase:III Field of study: hepatology. Study Period: 2011 - 2013 Principal Investigator: MD.Ph.D. Nikitin I.G.

30. Protocol M16-135: “An open study with one group evaluating the efficacy and safety of Glekaprevir (GLE) / Pibrentasvir (PIB) in patients with chronic hepatitis C genotype 1,2,4,5 or 6 and compensated cirrhosis who have not previously received treatment.” Research Sponsor:AbbVieINC., USA, Phase:III Field of study: hepatology. Study Period: 2018 Principal Investigator: MD.Ph.D. Nikitin I.G.

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS)

31. Protocol TMC435-TIDP16-C205: “A randomized, double-blind, placebo-controlled phase IIb study to study the efficacy, tolerability, safety and pharmacokinetics of TMS435 as part of a treatment regimen including peginterferon alfa-2a and ribavirin in patients with genotype 1 hepatitis C previously untreated. " Research Sponsor: TIBOTEC Pharmaceuticals Limited, Ireland, Phase:IIb Field of study:hepatology. Study Period: 2009 - 2011 Principal Investigator: MD.Ph.D. Nikitin I.G.

32. Protocol TMC435-TIDP16-C206: “A randomized, double-blind, placebo-controlled phase IIb study to study the efficacy, tolerability, safety and pharmacokinetics of TMS435 as part of a treatment regimen including peginterferon alfa-2a and ribavirin in patients with genotype 1 hepatitis C who have not received treatment before.” Research Sponsor: TIBOTEC Pharmaceuticals Limited, Ireland, Phase:IIb Field of study:hepatology. Study Period: 2009 - 2011 Principal Investigator: MD.Ph.D. Nikitin I.G.

33. Protocol TMC435-TIDP16-C208: “A randomized, double-blind, placebo-controlled phase III study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.” Research Sponsor: TIBOTEC Pharmaceuticals Limited, Ireland, Phase:III Field of study:hepatology. Study Period: 2010 - 2013 Principal Investigator: MD.Ph.D. Nikitin I.G.

34. Protocol TMC435HPC3007: “A randomized, double-blind, placebo-controlled phase III study to study the efficacy, safety, and tolerability of TMS435 compared to placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in patients with hepatitis C relapse, genotype 1 after previous treatment, including interferon.”

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) Research Sponsor: TIBOTEC Pharmaceuticals Limited, Ireland, Phase:III Field of study:hepatology. Study Period: 2010 - 2013 Principal Investigator: MD.Ph.D. Nikitin I.G.

35. Protocol CDEB025A2301: “A randomized, double-blind, placebo-controlled study of the efficacy and safety of a drug. DEB025 / Alisporivir, used in combination with standard therapy previously untreated patients infected with hepatitis C virus of genotype 1”. Research Sponsor:Novartis, USA, Phase:III Field of study:hepatology. Study Period: 2010 - 2013 Principal Investigator: MD.Ph.D. MD Nikitin I.G.

36. Protocol ID BI 1218.74: “A multicentre, international, randomised, parallel group, double blindstudy to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial”, Phase III. Sponsor: Beringer Ingelheim GmbH & Co. KG, Austria; representative: CRO Worldwide Clinical Trials Russia, LLC; Field of study: Endocrinology (Type 2 Diabetes). Study Period: 2011 - 2019 Principal Investigator: Ph.D. Gofman A.M.

37. Protocol ID BI 1218.17: «A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy». Sponsor: Beringer Ingelheim GmbH & Co. KG, Austria; representative: Worldwide Clinical Trials Russia, LLF. Field of study: Endocrinology (Type 2 Diabetes). Study Period: 2008-2009 Principal Investigator: Ph.D. Gofman A.M.

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 38. Protocol ID AGI-1067-052: “AGI-1067 as a Novel Antidiabetic Agent Evaluation Study” AGI-1067 (Succinobucol). Phase II Sponsor: AteroJenix, Inc. Alpharetta, USA; representative: Worldwide Clinical Trials Russia, LLF. Field of study: Endocrinology (Type 2 Diabetes). Study Period: 2007-2008 Principal Investigator: Ph.D. Gofman A.M.

39. Protocol ID 758-CL-010: “A randomized, double blind, placebo - controlled study to evaluate the safety, tolerability and preliminary efficacy 0f a four- week treatment with YM758 in subjects with stable angina” Phase III Sponsor: Astellas Pharma Inc. (Japan); representative: Parexel International Rus LLC Study Period: 2006-2008 Field of study: Cardiology Principal Investigator: Ph.D. Gofman A.M.

40. Protocol ID BI 1218.40: “A 78-week open label extension to trials assessing the safety and efficacy of BI 1356 (5 mg) as monotherapy or in combination with other antidiabetic medications in type 2 diabetic patients”. Phase III Sponsor: Beringer Ingelheim GmbH & Co. KG, Austria. Evidence Clinical and Pharmaceutical Resech, LLC (RUS) Field of study: Endocrinology (Type 2 Diabetes). Study Period: 2009-2010 Principal Investigator: Ph.D. Gofman A.M.

41. Protocol ID TP0203: “A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/day (800 mg tablets) for the Treatment of Active Ulcerative Colitis” Sponsor: Tillotts Pharma AG Field of study: gastroenterology Study Period: 2009-2009 Principal Investigator: Ph.D. Gofman A.M.

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 42. Protocol ID 1218.36 : “A Phase III randomised, double-blind, placebo-controlled, parallel group efficacy and safety study of Linagliptin (5 mg), administered orally once daily for at least 52 weeks in type 2 diabetic patients in combination with basal insulin therapy” Sponsor: Beringer Ingelheim GmbH & Co. KG, Austria; representative: CRO "Cromos" (RUS) Field of study: Endocrinology (Type 2 Diabetes). Study Period: 2010 - 2012 Principal Investigator: Ph.D. Gofman A.M.

43. Protocol ID CLCZ696B2314: «A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction», Phase III. Sponsor: " Novartis Pharma AG, Switzerland / LLC Novartis Pharma, RussiaField of study: Field of study: Cardiology, Chronic heart failure and reduced ejection fraction Study Period: 2010 - 2011 Principal Investigator: Ph.D. Gofman A.M.

44. Protocol ID DOR-1: “An open label randomized in parallel groups study of the efficacy and safety of the drug Domstal-O, consisting of a fixed combination of omeprazole 10 mg and domperidone 10 mg, in patients with gastroesophageal reflux disease". Phase 3 Sponsor: Torrent Pharmaceuticals Ltd., India. Field of study: gastroenterology Study Period: 2006 - 2006 Principal Investigator: Ph.D. Gofman A.M.

45. Protocol ID 1218.83: «A 24-week, randomized, double-blind, active-controlled, parallel group trial to assess the superiority of oral linagliptin and metformin compared to linagliptin monotherapy in newly diagnosed, treatmentnaïve, uncontrolled Type 2 Diabetes Mellitus patients» , Phase IV Sponsor: Beringer Ingelheim GmbH & Co. KG, Austria; representative: CRO "Cromos" (RUS) Field of study: Endocrinology (Type 2 Diabetes). Study Period: 2012 - 2013 Principal Investigator: Ph.D. Gofman A.M.

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 46. Protocol ID AMR-01-01-0019: “A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients with Cardiovascular Disease or at High Risk for Cardiovascular Disease:REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial)” Sponsor: Amarin Pharma Inc. Amarin Pharma Inc.,USA ; representative: Syneos Health RUS LLC Field of study: Cardiology (hypertriglyceridemia). Study Period: 2012 - 2019 Principal Investigator: Ph.D. Gofman A.M.

47. Protocol ID D4280C00004: “Phase III, Randomized, Multicenter, Double-Blind, Double- Dummy,Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram-Negative Pathogen in Hospitalized Adults” Sponsor: AstraZeneca Pharmaceuticals, LP; representative: LLC PPD Development Field of study: Urology, lower urinary tract infection Study Period: 2012 - 2015 Principal Investigator: Ph.D. Gofman A.M.

48. Protocol ID 1409R2121: «A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram- Negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin, Phase II Sponsor: Shionogi & Co., Ltd.,Japan; representative: Medpace, Inc. Field of study: Urology, lower urinary tract infection Study Period: 2014 - 2016 Principal Investigator: Ph.D. Gofman A.M.

49. Protocol ID CNTO1275: «A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis. Sponsor: Janssen-Cilag International NV, Belgium; representative: LLC Parexel International RUS Field of study: gastroenterology, Ulcerative Colitis Study Period: 2015 - 2017 Principal Investigator: Ph.D. Gofman A.M.

50. Protocol ID 129649CGH3001: “A multi-center, double-blind, randomized, parallel-group, placebo-controlled, two-phase study to determine the efficacy and safety of a benzocaine lozenge for symptomatic treatment of sore throat caused by acute upper respiratory tract infection in adults” Phase III Sponsor: Janssen-Cilag International NV, Belgium; representative: GCO/Janssen Pharmaceutica NV Field of study: Otolaryngology, throat infections Study Period: 2018 - 2018 Principal Investigator: Ph.D. Gofman A.M.

51. Protocol ID BP101-SD02-RUS: "A multicenter, double-blind, randomized, placebo- controlled phase III study to confirm the efficacy and safety of BP101 in patients with reduced or lost sexual desire." Phase 3 Sponsor: Ivix LLC, Russia Field of study: Endocrinology Study Period: 2017 -2018 Principal Investigator: Ph.D. Gofman A.M.

52. Protocol MMH-KOL-003: "A multicenter, double-blind, placebo-controlled, randomized clinical trial of the efficacy and safety of Colofort in the treatment of patients with functional dyspepsia." Phase 4 Sponsor: NPF “Materia Medica Holding” LLC, Russia. Field of study: Gastroenterology (functional dyspepsia). Study Period: 2018 -2019 Principal Investigator: Ph.D. Gofman A.M.

List of completed clinical studies based on the Central Clinical Hospital of the Russian Academy of Sciences (CCH RAS) 53. Study Protocol ID: A-38-52014-194 “Multicenter, maltinational (China and Russia), randomized, open, controlled study of immediate 9-month adjuvant hormone therapy with Tryptorelin 11.25 mg versus active surveillance after radical prostatectomy in high-risk prostate cancer patients”. Fase IIIa.

Sponsor: IPSEN PHARMA SAS Russia, China Field of study: Oncology (Prostate cancer) Study Period: 2013 -2019 Principal Investigator: MD.Ph.D. Kostin A.A.

51. Study Pronocol ID: D4280C00016 «Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)». Fase III. Sponsor: AstraZeneca Field of study: Pediatrics, Urology Study period: 2015 -2017 Principal investigator: MD.Ph.D. Turti T.V.

52. Study Pronocol ID: 3005031 «Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU». Fase III. Sponsor: Orion Pharma Field of study: Pediatrics Study period: 2017 -2018 Principal investigator: MD.Ph.D. Turti T.V.