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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2024
• Main ID: NCT04058158
• Date of registration: 12/08/2019
• Prospective Registration: No
• Primary sponsor: Samsung Bioepis Co., Ltd.
• Public title: A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
• Scientific title: A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal Haemoglobinuria
• Date of first enrolment: August 7, 2019
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04058158
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

India, Korea, Republic of, Malaysia, Mexico, Romania, Taiwan, Thailand, Ukraine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Intervention(s)

Drug: Soliris (eculizumab)

Drug: SB12 (proposed eculizumab biosimilar)

Primary Outcome(s)

Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52 [Time Frame: From Week 14 to Week 26 and from Week 40 to Week 52]

Lactate Dehydrogenase (U/L) at Week 26 [Time Frame: Week 26]

Secondary ID(s)

SB12-3003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/03/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT04058158