A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

NCT ID: NCT04058158

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-07
• Study Completion Date: 2021-10-21

Brief Summary

This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.

Detailed Description

Subjects will be randomised in a 1:1 ratio to either treatment sequence. Subjects randomly assigned to treatment with SB12 or Soliris® will receive 600 mg of eculizumab IV every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks until Week 52. Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® and subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26.

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Sequence I

Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26

Group Type: EXPERIMENTAL

SB12 (proposed eculizumab biosimilar)

Intervention Type: DRUG

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Soliris (eculizumab)

Intervention Type: DRUG

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Treatment Sequence II

Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26

Group Type: EXPERIMENTAL

SB12 (proposed eculizumab biosimilar)

Intervention Type: DRUG

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Soliris (eculizumab)

Intervention Type: DRUG

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Interventions

SB12 (proposed eculizumab biosimilar)

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Intervention Type: DRUG

Soliris (eculizumab)

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female aged 18 or older
• Eculizumab-naïve patients with PNH
• Presence of the PNH white blood cell (WBC) clone ≥ 10%
• Documented LDH level ≥ 1.5 x ULN at Screening
• History of transfusion for anaemia within 12 months prior to Screening or having PNH-related symptoms at Screening
• Subjects must be vaccinated against Neisseria meningitides

Exclusion Criteria

• Previous treatment with any complement pathway inhibitors
• ANC ≤ 500/mm3 or Platelet count < 70,000/mm3
• History of meningococcal disease
• History of bone marrow transplantation
• Known or suspected active bacterial/viral/fungal infection within 30 days
• Stable use of erythropoietic, corticosteroids, heparin, warfarin before randomisation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fortis Memorial Research Institute

Gurgaon, Haryana, India

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, , India

Apollo Hospitals International Limited

Chennai, , India

Amrita Institute of Medical Sciences and Research Centre

Kochi, , India

Nil Ratan Sircar Medical College and Hospital

Kolkata, , India

Hospital Ampang

Ampang, , Malaysia

Hospital Sultanah Aminah

Johor Bahru, , Malaysia

Queen Elizabeth Hospital - Kota Kinabalu

Kota Kinabalu, , Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, , Malaysia

Hospital Pulau Pinang

Pulau Pinang, , Malaysia

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Tlalpan, , Mexico

Colentina Clinical Hospital

Bucharest, , Romania

Emergency University Hospital

Bucharest, , Romania

Prof Dr I Chiricuta Institute of Oncology

Cluj-Napoca, , Romania

Filantropia Municipal Clinical Hospital

Craiova, , Romania

Samsung Medical Center

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Chulalongkorn University

Bangkok, , Thailand

Srinagarind Hospital

Nai Muang, , Thailand

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov

Vinnytsia, Vinnytsia Oblast, Ukraine

Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council

Cherkasy, , Ukraine

Communal Non-profit Enterprise Regional Center of Oncology

Kharkiv, , Ukraine

Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi

Poltava, , Ukraine

Countries

India; Malaysia; Mexico; Romania; South Korea; Taiwan; Thailand; Ukraine

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SB12-3003

Identifier Type: -

Identifier Source: org_study_id