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NCT Number: NCT04673786

A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis

This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Centre

Tartu, Tartu Country, Estonia, 50106, Estonia

About this study

CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients with moderate to severe plaque psoriasis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.

Exclusion criteria

  • Patients diagnosed with forms of psoriasis other than plaque-type.
  • Patients previously received ustekinumab or a biosimilar of ustekinumab.
  • Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.

Treatment and study plan

CT-P43

Biological

45mg or 90mg dose subcutaneous administration

Stelara

Biological

45mg or 90mg dose subcutaneous administration

Primary outcomes

  1. The Mean Percent Improvement From Baseline in PASI Score at Week 12

    Time frame: From baseline to Week 12

    The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

Secondary outcomes

  1. The PASI Scores at Week 12

    Time frame: Week 12

    The Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

  2. The Mean Percent Improvement From Baseline in PASI Score Through Week 52

    Time frame: Through Week 52

    The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score through Week 52. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

  3. The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12

    Time frame: Week 12

    The number of participants achieving at least 50%/75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).

  4. The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12

    Time frame: Week 12

    The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the erythema, average thickness, and scaling of all psoriatic lesions at a given time point. The sum of the 3 scales will be divided by 3 to obtain a final sPGA score.

  5. The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52

    Time frame: Through Week 52

    This DLQI is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Total scores range from 0 to 30 (less to more impairment).

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Moderate to Severe Plaque Psoriasis

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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