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الإدارة العامة للدراسات الإكلينيكية- إدارة للبروتوكولات ومتابعة اجراء الدراسات

ملخص التقيم العلمي والفني للتجارب السريرية لهيئة الدواء المصرية ٢٠٢٦

ملخص التقيم العلمي والفني للتجارب السريرية لهيئة الدواء المصرية 2026

Protocol ID/Number

Protocol Title

Product Name/Dosage Form

Sponsor

Date of publishing
CNTO1959CRD3005

A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease

Guselkumab 

Janssen Scientific and Medical Affairs

01/07/2026
CNBG2020003SQ

Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and immunogenicity of Inactivated SARS-CoV-2 Vaccines in Healthy Population Aged 18 years old and above

Inactivated SARS-CoV-2 Vaccines

China National Biotec Group Company Limited (CNBG)

Wuhan Institute of Biological Products Co., Ltd. (WIBP) (A subsidiary institute under CNBG)
Beijing Institute of Biological Products Co., Ltd. (BIBP) (A subsidiary institute under CNBG)
28/06/2026
01-Sputnik-Light-2021

A Phase III, Randomized, Double Blind, Placebo-Controlled International Multisite Clinical Trial in Parallel Assignment to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik Light Vector Vaccine in Adults in the SARS-CoV-2 Infection Prophylactic Treatment

Sputnik Light Vector Vaccine

The Global Sponsor: Human Vaccine LLC
-Vaccine Development Company and Local Sponsor in Russia: Russian Ministry of Healthcare FGBU N.F. Gamaleya Scientific Research Center of Epidemiology and Microbiology

28/06/2026

A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination with Tremelimumab ± Lenvatinib Given Concurrently with Transarterial Chemoembolization (TACE) Compared to TACE Alone in Patients with Locoregional Hepatocellular Carcinoma

Durvalumab

AstraZeneca 

22/06/2026

Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination with Bevacizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Durvalumab

AstraZeneca 

21/06/2026
GBT2104-131 (C5361001)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vaso-occlusive Crises

Inclacumab 

Global Blood Therapeutics, Inc. “GBT”, a wholly owned subsidiary of Pfizer Inc.

18/05/2026
COVID_VACC_1

Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Inactivated SARS-CoV-2 Vaccine Against COVID-19 in Healthy Adults.

Inactivated SARS-CoV-2 Vaccine

National Research Centre (NRC)

12/5/2026
DAY101-002 

A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

Tovorafenib

Day One Biopharmaceuticals, Inc. (Day One)

11/5/2026
M20-465

A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa

Lutikizumab 

Abbvie 

05/05/2026
MOM-M281-006

Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia:

 A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension

M281

 Janssen Research & Development, LLC

30/04/2026
SPHINX22122020

Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of SARS CoV-2 Infection (COVID-19)

EgyVax Vaccine

EVA PHARMA, Veterinary Serum & Vaccine Research Institute (VSVRI), the Supreme Council of University Hospitals, and the Ministry of Higher Education and Scientific Research

26/04/2026
MO42541 (Imbrave)

A Phase III, Open-Label, Randomized Study of Atezolizumab with Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib alone in Hepatocellular Carcinoma Previously Treated with Atezolizumab and Bevacizumab

Atezolizumab  F. Hoffmann-La Roche Ltd 22/04/2026
START24042025

Adhesion and Safety of Rotigexole Compared to Neupro®: A Non-Inferiority Open-Labelled Crossover Randomized Controlled Trial

Rotigexole EVA Pharma, Egypt 21/04/2026
MN39159 “Consonance study”

An open Label, Single-arm, 4-year study to evaluate effectiveness and safety of Ocrelizumab treatment in patients with progressive multiple sclerosis

MN39159 F. Hoffmann-La-Roche Ltd  15/04/2026
GA45332

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the
Efficacy and Safety of Induction Therapy with RO7790121 in Patients with Moderately to Severely
Active Crohn's Disease

RO7790121 F. Hoffmann-La-Roche Ltd 30/3/2026
NN7535-7822 (FLORAL)

An Open-Label, Multi-Centre, Rollover Study to Characterise Long-Term Safety and Efficacy of Etavopivat in Adults, Adolescents and Children who Have Sickle Cell Disease or Thalassemia and Have Completed a Treatment Period in an Etavopivat Study 

Etavopivat Film-coated tablet Novo Nordisk A/S 09/03/2026
GA45331

A Phase III, Multicenter, Double blind , Placebo -controlled, treat through study to assess the efficacy and safety of Induction and Maintenance Therapy with RO7790121in patients with Moderately to severely active Crohn's disease

RO7790121 F. Hoffmann-La-Roche Ltd 01/03/2026

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