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

NCT04058158 | Completed Phase 3 Results

• 1 other identifier: SB12-3003
• Study Type: interventional
• Target: 50
• Locations: 8 countries
• Sites: 27

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.

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Treatment Sequence I

EXPERIMENTAL

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

Drug: SB12 (proposed eculizumab biosimilar); Drug: Soliris (eculizumab)

Treatment Sequence II

EXPERIMENTAL

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

Drug: SB12 (proposed eculizumab biosimilar); Drug: Soliris (eculizumab)

Interventions

SB12 (proposed eculizumab biosimilar) 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 I; Treatment Sequence II

Soliris (eculizumab) 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 I; Treatment Sequence II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (27)

Fortis Memorial Research Institute

Gurgaon, Haryana, 122002, India

Location

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, India

Location

Apollo Hospitals International Limited

Chennai, India

Location

Amrita Institute of Medical Sciences and Research Centre

Kochi, India

Location

Nil Ratan Sircar Medical College and Hospital

Kolkata, India

Location

Hospital Ampang

Ampang, Malaysia

Location

Hospital Sultanah Aminah

Johor Bahru, Malaysia

Location

Queen Elizabeth Hospital - Kota Kinabalu

Kota Kinabalu, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Location

Hospital Pulau Pinang

Pulau Pinang, Malaysia

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Tlalpan, Mexico

Location

Colentina Clinical Hospital

Bucharest, Romania

Location

Emergency University Hospital

Bucharest, Romania

Location

Prof Dr I Chiricuta Institute of Oncology

Cluj-Napoca, Romania

Location

Filantropia Municipal Clinical Hospital

Craiova, Romania

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Chulalongkorn University

Bangkok, Thailand

Location

Srinagarind Hospital

Nai Muang, Thailand

Location

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

Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

Location

Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council

Cherkasy, 18009, Ukraine

Location

Communal Non-profit Enterprise Regional Center of Oncology

Kharkiv, Ukraine

Location

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

Poltava, Ukraine

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Interventions

zwittergent 3-12; eculizumab

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd

sbregistry@samsung.com

+82-32-728-0371

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 15, 2019
• Study Start: August 7, 2019
• Primary Completion: September 21, 2021
• Study Completion: October 21, 2021
• Last Updated: March 26, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-03

Locations

TH (2); MY (5); UA (4); TW (4); KR (2); RO (4); IN (5); ME (1)