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

Phase 3

Completed

• Conditions: Paroxysmal Nocturnal Hemoglobinuria
• Interventions: Drug: SB12 (proposed eculizumab biosimilar); Drug: Soliris (eculizumab)

• Registration Number: NCT04058158
• Lead Sponsor: Samsung Bioepis Co., Ltd.

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 sw...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2019-08-07
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Primary Completion: 2021-09-21
• Study Completion: 2021-10-21
• Results First Submitted: 2023-09-14
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Results First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence I	SB12 (proposed eculizumab biosimilar)	Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26
Treatment Sequence II	SB12 (proposed eculizumab biosimilar)	Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26
Treatment Sequence II	Soliris (eculizumab)	Subjects who are randomised to initially receive Soliris® will be switched to receive SB12 at Week 26
Treatment Sequence I	Soliris (eculizumab)	Subjects who are randomised to initially receive SB12 will be switched to receive Soliris® at Week 26

Primary Outcome Measures

Name	Time	Method
Lactate Dehydrogenase (U/L) at Week 26	Week 26
Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52	From Week 14 to Week 26 and from Week 40 to Week 52

Trial Locations

Locations (27)

Fortis Memorial Research Institute; 🇮🇳 Gurgaon, Haryana, India

Hospital Sultanah Aminah; 🇲🇾 Johor Bahru, Malaysia

Hospital Pulau Pinang; 🇲🇾 Pulau Pinang, Malaysia

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Tlalpan, Mexico

Colentina Clinical Hospital; 🇷🇴 Bucharest, Romania

Hospital Ampang; 🇲🇾 Ampang, Malaysia

Prof Dr I Chiricuta Institute of Oncology; 🇷🇴 Cluj-Napoca, Romania

Hospital Tengku Ampuan Afzan; 🇲🇾 Kuantan, Malaysia

Queen Elizabeth Hospital - Kota Kinabalu; 🇲🇾 Kota Kinabalu, Malaysia

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Filantropia Municipal Clinical Hospital; 🇷🇴 Craiova, Romania

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

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; 🇮🇳 Cochin, India

Nil Ratan Sircar Medical College and Hospital; 🇮🇳 Kolkata, India

Emergency University Hospital; 🇷🇴 Bucharest, Romania

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

Chulalongkorn University; 🇹🇭 Bangkok, Thailand

Srinagarind Hospital; 🇹🇭 Nai Muang, Thailand

Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi; 🇺🇦 Poltava, Ukraine

Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council; 🇺🇦 Cherkasy, Ukraine

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Communal Non-profit Enterprise Regional Center of Oncology; 🇺🇦 Kharkiv, Ukraine

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov; 🇺🇦 Vinnytsia, 'Vinnyts'ka Oblast, Ukraine