Clinical trial NCT04058158: A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lactate Dehydrogenase (U/L) at Week 26
timeFrame: Week 26
measure: Time-adjusted AUEC of LDH From Week 14 to Week 26 and From Week 40 to Week 52
timeFrame: From Week 14 to Week 26 and from Week 40 to Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
state: Haryana
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research (PGIMER)
city: Chennai
country: India
facility: Apollo Hospitals International Limited
city: Cochin
country: India
facility: Amrita Institute of Medical Sciences and Research Centre
city: Kolkata
country: India
facility: Nil Ratan Sircar Medical College and Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ampang
country: Malaysia
facility: Hospital Ampang
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth Hospital - Kota Kinabalu
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Bucharest
country: Romania
facility: Emergency University Hospital
city: Cluj-Napoca
country: Romania
facility: Prof Dr I Chiricuta Institute of Oncology
city: Craiova
country: Romania
facility: Filantropia Municipal Clinical Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Nai Muang
country: Thailand
facility: Srinagarind Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov
state: 'Vinnyts'ka Oblast
city: Cherkasy
country: Ukraine
facility: Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council
city: Kharkiv
country: Ukraine
facility: Communal Non-profit Enterprise Regional Center of Oncology
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi
Study officials:
References: