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IRCT20150303021315N37 IRCT 2025-07-11 AryoGen Pharmed Company Non-inferiority evaluation of dupilumab (AryoGen) VS. Dupixent® (Regeneron & Sanofi) A phase III, randomized, two-armed, double-blind, multicenter, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of dupilumab (AryoGen Co.) versus Dupixent® (Regeneron & Sanofi Co.) in patients with moderate to severe atopic dermatitis 2025-11-12 anticipated 250 Recruiting https://irct.ir/trial/83416 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Patient allocation will be performed using R-CRAN version 4.4.0, applying block randomization (sizes 2 and 4), stratified by IGA (moderate/severe), for 250 patients with a 1:1 ratio. The randomization list and seed will be sent to the CRO (Contract Research Organization) before the study and used under CRO supervision to assign patients to groups during the study. This process will be centrally managed, with each patient randomly allocated to a treatment group upon entry according to their stratum. Each patient will receive a code consisting of four letters (first two of first and last names), three numbers (center code), three letters (DUP), and three digits (randomization code), e.g., ABCD001DUP-001. Randomization numbers will be assigned sequentially, Blinding description: Both interventions are non-distinguishable for patients and clinical staff.The drug containers of both dupilumab formulations will be placed in identical packaging, making them indistinguishable in appearance. 3 Atopic dermatitis. Intervention 1: Intervention Group :Dupilumab (AryoGen Co., Iran) 300 mg/ 2mL for sub-cutaneous injectionDupilumab 600 mg, Sub-cutaneous injection, at day 0, then Dupilumab 300 mg at weeks 2, 4, 6, 8, 10, 12, and 14. Intervention 2: Control group: Dupixent® (Regeneron & Sanofi Co.) 300 mg/ 2mL for sub-cutaneous injectionDupilumab 600 mg, Sub-cutaneous injection, at day 0, then Dupilumab 300 mg at weeks 2, 4, 6, 8, 10, 12, and 14. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamidreza Kafi
No 42, Attar street, Vanak square, Tehran
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 Kafi.H@orchidpharmed.com Orchid Pharmed Co scientific Alireza Firooz
Center for Research in Skin Diseases and Leprosy, No. 415, Corner of Naderi Street (formerly Soheil Street), Shahid Taleqani Street
Tehran Iran (Islamic Republic of) 1416613675 +98 912 109 4901 firozali@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18-75 years (patients with the age of 18 and 75 will be enrolled too) Have a diagnosis of chronic Atopic Dermatitis (based on American Academy of Dermatology Consensus Criteria 2014), for at least 3 months before the screening Moderate-to-severe Atopic Dermatitis patients with an EASI ≥16 at screening and before the first administration of the study drug • Eczema Area and Severity Index (EASI) is a tool to assess the severity and extent of atopic eczema, which would be scored based on physician’s diagnosis. It is scored from 0-72, where a greater number indicates of more severe disease.• If EASI score is 14 or 15 at screening, re-evaluation within 48 hours after the first assessment is possible. Have an involved BSA ≥10 percent at screening• Body Surface Area (BSA) is scored based on physician’s diagnosis, which indicates the extent of disease involvement thorugh skin lesions. A greater number indicates of more severe disease. Have an IGA ≥3 at screening• Investigator’s Global Assessment (IGA) is a 5-score (0-4) index which is scored based on physician’s judgement to report the severity of the disease. A greater number indicates of more severe disease. History of inadequate response to treatment with topical corticosteroids• Inadequate response to treatment definition: no proper response to medium to high potency topical corticosteroids for 4 weeks or history of receiving systemic treatment for atopic dermatitis. Ability to comprehend and willingness to sign the informed consent form for this study. 18 years 75 years Both Pregnant or nursing women, or women planning a pregnancy during the study Has previously received dupilumab Treatment with biologics as follows:- Any cell-depleting agents such as rituximab, ocrelizumab and belimumab within 6 months before the screening, Other biologics such as anti-TNFs (like adalimumab) and Interleukin-6 inhibitors (like tocilizumab) within 5 half-lives or 16 weeks prior to screening (whichever is longer) Phototherapy, laser therapy, or regular use of a tanning booth/parlor (more than 2 times per week) within 4 weeks before the screening Having used any of the following systemic immunosuppressants / immunomodulators within 4 weeks before the first administration of the study intervention: Systemic corticosteroids, Cyclosporine, Mycophenolate-mofetil, Janus kinase inhibitors, Azathioprine, Methotrexate Has received any investigational agent/drug within 30 days or passing less than 5 half-lives of the investigational agent (whichever is longer) before the first administration of the study intervention or participating in clinical studies consisting of any investigational agent or procedure. Has received, or is planning to receive, any live virus or bacterial vaccination within 12 weeks before the first administration of the study intervention. Chronic or acute infections requiring systemic treatment with antibiotics, antivirals, antiparasitics such as anthelmintics, antiprotozoals, or antifungals within 2 weeks before the first administration of the study intervention, or superficial skin infections within 1 week before the first administration of the study intervention History or diagnosis of hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV) infection History or diagnosis of malignancy within 5 years before the screening (except treated in situ carcinoma of the cervix and resolved non-metastatic squamous or basal cell carcinoma of the skin) Has any plan of major surgical procedure during the study Substance abuse, dermatologic disease such as psoriasis or alopecia areata or any other condition (such as active major autoimmune diseases (like lupus or inflammatory bowel disease), severe renal failure (patients undergoing dialysis), moderate to severe hepatic disorders (ALT or AST more than 100 IU/L), or stage III or IV of cardiac failure according to the New York Heart Association (NYHA) classification) which, in the opinion of the investigator, will make the subject inappropriate for enrolling the study or that could limit or confound the protocol-specified assessments L20.9 Atopic dermatitis, unspecified Treatment - Drugs Treatment - Drugs Intervention Group :Dupilumab (AryoGen Co., Iran) 300 mg/ 2mL for sub-cutaneous injectionDupilumab 600 mg, Sub-cutaneous injection, at day 0, then Dupilumab 300 mg at weeks 2, 4, 6, 8, 10, 12, and 14 Control group: Dupixent® (Regeneron & Sanofi Co.) 300 mg/ 2mL for sub-cutaneous injectionDupilumab 600 mg, Sub-cutaneous injection, at day 0, then Dupilumab 300 mg at weeks 2, 4, 6, 8, 10, 12, and 14 Proportion of patients achieving EASI 75 at week 16. Timepoint: Screening/ Week 0, Week 16. Method of measurement: Physician assessment based on EASI questionnaire. Proportion of patients achieving EASI 90 at week 16. Timepoint: Screening/ Week 0, Week 16. Method of measurement: Physician assessment based on EASI questionnaire. Proportion of patients achieving EASI 50 at week 16. Timepoint: Screening/ Week 0, Week 16. Method of measurement: Physician assessment based on EASI questionnaire. The changes in patients’ itching based on NRS from week 0 to week 16. Timepoint: Week 0, Week 16. Method of measurement: NRS questionnaire. Proportion of patients achieving IGA 0 or 1 at week 16. Timepoint: Screening, Week 16. Method of measurement: Physician assessment based on IGA questionnaire. The changes of DLQI score from week 0 to week 16. Timepoint: Week 0, Week 16. Method of measurement: DLQI questionnaire. Assessment of adverse events. Timepoint: During all scheduled visits. Method of measurement: Clinical monitoring. Assessment of immunogenicity( Assessment of anti-drug antibody (ADA) development in patients.). Timepoint: Screening, weeks 8 and 16. Method of measurement: electrochemiluminescence immunoassay. AryoGen Pharmed Company Approved 2025-06-09 Ethics Committee of Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Ghods street, Keshavarz boulevard, Tehran Tehran Tehran Iran (Islamic Republic of)