CompletedNCT04673786Updated Jun 5, 2023Results posted

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

A Phase 3 interventional study of CT-P43 and Stelara in Psoriasis, sponsored by Celltrion. Completed at 1 site in Estonia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by Celltrion · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 509
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Psoriasis

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Psoriasis 1,899

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 509 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Celltrion is the lead sponsor of 76 studies on the registry; 3 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 13 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 509 participants (actual)

Study arms

Experimental
CT-P43
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
Active comparator
Stelara
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-P43 · Biological: Stelara

Interventions

BiologicalCT-P43
45mg or 90mg dose subcutaneous administration
BiologicalStelara
45mg or 90mg dose subcutaneous administration

What researchers measure

Primary outcomes

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).
Time frame: From baseline to Week 12

Secondary outcomes

The PASI Scores at 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).
Time frame: Week 12
The Mean Percent Improvement From Baseline in PASI Score 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).
Time frame: Through Week 52
The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at 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).
Time frame: Week 12
The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at 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.
Time frame: Week 12
The Change From Baseline in Dermatology Life Quality Index (DLQI) 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).
Time frame: Through Week 52

Results

Posted Jun 5, 2023

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.

Participant flow

Treatment Period I (Weeks 0 to 16)

Participant flow — Treatment Period I (Weeks 0 to 16)
Milestone	CT-P43	EU-Stelara
Started	256	253
Completed	253	249
Not completed	3	4
Withdrew: Withdrawal by subject	3	3
Withdrew: Lost to follow-up	0	1

Treatment Period II (Weeks 16 to 52)

Participant flow — Treatment Period II (Weeks 16 to 52)
Milestone	CT-P43	EU-Stelara	Switched to CT-P43
Started	253	125	124
Completed	239	122	122
Not completed	14	3	2
Withdrew: Withdrawal by subject	9	3	1
Withdrew: Lost to follow-up	2	0	0
Withdrew: Death	1	0	0
Withdrew: Adverse event	2	0	1

Outcome measures

PrimaryThe 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).

Time frame:: From baseline to Week 12
Reported as:: Least squares mean · percentage of improvement in PASI score

The Mean Percent Improvement From Baseline in PASI Score at Week 12
percentage of improvement in PASI score	CT-P43	EU-Stelara
The Mean Percent Improvement From Baseline in PASI Score at Week 12	77.93 ± 1.771	75.89 ± 1.739

Statistical analysis

CT-P43 vs EU-Stelara · ANCOVA · Treatment difference (%) and 90% ci: 2.05 · 90% CI -0.23 to 4.32Multiple imputation (MI) with the Missing at random (MAR) assumption was applied.

SecondaryThe PASI Scores at 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).

Time frame:: Week 12
Reported as:: Mean · score on a scale

The PASI Scores at Week 12
score on a scale	CT-P43	EU-Stelara
The PASI Scores at Week 12	2.98 ± 3.412	3.44 ± 4.362

SecondaryThe Mean Percent Improvement From Baseline in PASI Score 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).

Time frame:: Through Week 52
Reported as:: Mean · percentage of improvement in PASI score

The Mean Percent Improvement From Baseline in PASI Score Through Week 52
percentage of improvement in PASI score	CT-P43 Maintenance	EU-Stelara Maintenance	Switched to CT-P43
The Mean Percent Improvement From Baseline in PASI Score Through Week 52	93.79 ± 11.794	93.39 ± 14.947	91.58 ± 13.264

SecondaryThe Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at 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).

Time frame:: Week 12
Reported as:: Count of participants · Participants

The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12
Participants	CT-P43	EU-Stelara
PASI 50	247	240
PASI 75	212	187
PASI 90	129	127
PASI 100	47	48

SecondaryThe Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at 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.

Time frame:: Week 12
Reported as:: Count of participants · Participants

The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12
Participants	CT-P43	EU-Stelara
The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12	219	201

SecondaryThe Change From Baseline in Dermatology Life Quality Index (DLQI) 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).

Time frame:: Through Week 52
Reported as:: Mean · score on a scale

The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52
score on a scale	CT-P43 Maintenance	EU-Stelara Maintenance	Switched to CT-P43
The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52	-10.5 ± 7.24	-8.5 ± 7.17	-9.2 ± 6.93

Adverse events

Collected over Through 52 weeks. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment Period I: CT-P43	0/256 (0%)	4/256 (1.6%)	14/256 (5.5%)
Treatment Period I: EU-Stelara	0/253 (0%)	4/253 (1.6%)	20/253 (7.9%)
Treatment II: CT-P43 Maintenance	1/253 (0.4%)	5/253 (2%)	35/253 (13.8%)
Treatment Period II: EU-Stelara Maintenance	0/125 (0%)	3/125 (2.4%)	25/125 (20%)
Treatment Period II: Switched to CT-P43	0/124 (0%)	2/124 (1.6%)	28/124 (22.6%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Treatment Period I: CT-P43	Treatment Period I: EU-Stelara	Treatment II: CT-P43 Maintenance	Treatment Period II: EU-Stelara Maintenance	Treatment Period II: Switched to CT-P43
NephrolithiasisRenal and urinary disorders	0/256	0/253	0/253	0/125	1/124
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/256	0/253	0/253	0/125	1/124
COVID-19 pneumoniaInfections and infestations	2/256	1/253	0/253	1/125	0/124
COVID-19Infections and infestations	0/256	0/253	0/253	1/125	0/124
Guillain-Barre syndromeNervous system disorders	0/256	0/253	0/253	1/125	0/124
Subarachnoid haemorrhageNervous system disorders	0/256	1/253	0/253	0/125	0/124
Abortion spontaneousPregnancy, puerperium and perinatal conditions	0/256	1/253	0/253	0/125	0/124
Menstrual disorderReproductive system and breast disorders	0/256	1/253	0/253	0/125	0/124
Myocardial infarctionCardiac disorders	0/256	0/253	1/253	0/125	0/124
Pancreatitis acuteGastrointestinal disorders	0/256	0/253	1/253	0/125	0/124

Most frequent other events

Most frequent other events
Event	Treatment Period I: CT-P43	Treatment Period I: EU-Stelara	Treatment II: CT-P43 Maintenance	Treatment Period II: EU-Stelara Maintenance	Treatment Period II: Switched to CT-P43
COVID-19Infections and infestations	11/256	12/253	13/253	11/125	7/124
Upper respiratory tract infectionInfections and infestations	3/256	8/253	10/253	4/125	7/124
Alanine aminotransferase increasedInvestigations	0/256	0/253	3/253	3/125	6/124
Latent tuberculosisInfections and infestations	0/256	0/253	7/253	4/125	4/124
NasopharyngitisInfections and infestations	0/256	0/253	1/253	1/125	4/124
Aspartate aminotransferase increasedInvestigations	0/256	0/253	2/253	3/125	4/124
HypertriglyceridaemiaMetabolism and nutrition disorders	0/256	0/253	4/253	1/125	4/124

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CT-P43	EU-Stelara	Total
Mean	42.6 ± 13.00	42.2 ± 12.64	42.4 ± 12.81

Sex: Female, Male
Sex: Female, Male(Participants)	CT-P43	EU-Stelara	Total
Female	95	80	175
Male	161	173	334

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CT-P43	EU-Stelara	Total
American Indian or Alaska Native	0	0	0
Asian	25	23	48
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	231	230	461
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	CT-P43	EU-Stelara	Total
Estonia	5	6	11
South Korea	25	23	48
Poland	189	188	377
Ukraine	37	36	73

Study locations

1 site

Clinical Research Centre
Tartu, Tartu Country, Estonia 50106, Estonia

References and documents

Study documents

Study protocol · Jul 14, 2021
Statistical analysis plan · Jun 22, 2022

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04673786
Lead sponsor: Celltrion
Responsible party: Sponsor
First posted: Dec 17, 2020
Start date: Jan 11, 2021
Primary completion: Aug 4, 2021
Completion: May 12, 2022
Results posted: Jun 5, 2023
Last update: Jun 5, 2023

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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