To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (omalizumab)

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Chronic Spontaneous Urticaria

Treatments: Biological: CT-P39; Biological: EU-approved Xolair

Study type: Interventional

Funder types: Industry

Identifiers

NCT04426890

CT-P39 3.1

2020-000952-36 (EudraCT Number)

Details and patient eligibility

About

A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 3 Study to Compare Efficacy and Safety of CT-P39 and Xolair in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic despite H1 antihistamine Treatment

Full description

CT-P39, containing the active ingredient omalizumab, is a recombinant humanized monoclonal antibody that is being developed and manufactured as a proposed biosimilar to Xolair (omalizumab) by the Sponsor. CT-P39 is identical to Xolair with respect to concentration and presentation. The 150 mg of drug product (CT-P39) will have the same pharmaceutical form and strength as 150 mg Xolair (in a prefilled syringe [PFS] for subcutaneous injection) and is intended to have a similar quality profile compared with Xolair.

Enrollment: 634 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with CSU
• Diagnosed as CSU refractory to H1-antihistamine

Exclusion criteria

• Chronic urticaria with clearly defined underlying etiology
• Clinically significant allergic reaction and/or hypersensitivity to any component of omalizumab
• History of anaphylactic shock
• History of and/or concomitant immune complex disease (including Type III hypersensitivity)
• Parasitic diseases or colonization on stool evaluation for ova and parasites
• Unable to receive background therapy with protocol-defined antihistamines or contraindicated to epinephrine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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634 participants in 6 patient groups

Arm 1

Experimental group

Description:

Planned to receive CT-P39 300 mg every 4 weeks in Treatment Period 1 (TP1) and maintain CT-P39 300 mg in TP2

Treatment:

Biological: CT-P39

Arm 2

Active Comparator group

Description:

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized at Week 12 to Arm 2-1 or Arm 2-2

Treatment:

Biological: EU-approved Xolair

Arm 2-1

Active Comparator group

Description:

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to switch to CT-P39 300 mg in TP2

Treatment:

Biological: EU-approved Xolair

Biological: CT-P39

Arm 2-2

Active Comparator group

Description:

Planned to receive Xolair 300 mg every 4 weeks in TP1 and be re-randomized to maintain Xolair 300 mg in TP2

Treatment:

Biological: EU-approved Xolair

Arm 3

Experimental group

Description:

Planned to receive CT-P39 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to CT-P39 300 mg in TP2

Treatment:

Biological: CT-P39

Arm 4

Active Comparator group

Description:

Planned to receive Xolair 150 mg every 4 weeks in Treatment Period 1 (TP1) and increase to Xolair 300 mg in TP2

Treatment:

Biological: EU-approved Xolair