NCT04673786

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

December 13, 2020

Results QC Date

May 3, 2023

Last Update Submit

June 1, 2023

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • The Mean Percent Improvement From Baseline in PASI Score at 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).

    From baseline to Week 12

Secondary Outcomes (5)

  • The PASI Scores at Week 12

    Week 12

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

    Through Week 52

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

    Week 12

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

    Week 12

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

    Through Week 52

Study Arms (2)

CT-P43

EXPERIMENTAL

All patients who were initially randomized to the CT-P43 group on Day 1 (Week 0) will continue their treatment with CT-P43 until Week 40.

Biological: CT-P43

Stelara

ACTIVE COMPARATOR

Patients who were initially randomized to Stelara group on Day 1 (Week 0) will be randomized again in a ratio of 1:1 to either continue Stelara or undergo transition to CT-P43 prior to dosing at Week 16. Thereafter, patients will continue their treatment until Week 40.

Biological: CT-P43Biological: Stelara

Interventions

CT-P43BIOLOGICAL

45mg or 90mg dose subcutaneous administration

CT-P43Stelara
StelaraBIOLOGICAL

45mg or 90mg dose subcutaneous administration

Stelara

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre

Tartu, Tartu Country, Estonia, 50106, Estonia

Location

Related Publications (1)

  • Papp KA, Lebwohl MG, Thaci D, Jaworski J, Kwiek B, Trefler J, Dudek A, Szepietowski JC, Reznichenko N, Narbutt J, Baran W, Kolinek J, Daniluk S, Bartnicka-Maslowska K, Reich A, Andrashko Y, Kim S, Bae Y, Jeon D, Jung J, Lee H, Pyo T, Ko W. Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study. BioDrugs. 2024 Jan;38(1):121-131. doi: 10.1007/s40259-023-00630-5. Epub 2023 Nov 22.

    PMID: 37991693DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Due to the conflict in Ukraine, sponsor provided guideline for exceptional allowance regarding visit window and study assessments (only EOS visit was affected) in order to ensure patients' safety and the robustness and integrity of data.

Results Point of Contact

Title
Head of Clinical Planning
Organization
CELLTRION, Inc.
YunJu.Bae@celltrion.com
+82-32-850-4160

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2020

First Posted

December 17, 2020

Study Start

January 11, 2021

Primary Completion

August 4, 2021

Study Completion

May 12, 2022

Last Updated

June 5, 2023

Results First Posted

June 5, 2023

Record last verified: 2023-06

Locations

ES(1)