PsoriasisPhase 3NCT04673786

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

A Phase 3 study testing CT-P43 and Stelara in people with Psoriasis, run by Celltrion at 1 site in Estonia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Psoriasis
What is being tested?: CT-P43 and Stelara
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 509 participants
Where: 1 siteEstonia
Study dates: 11 Jan 2021to 12 May 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Estonia1 site

Clinical Research Centre
Tartu, Tartu Country, Estonia, 50106

Other trials in Estonia

About this study

Official 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

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: Psoriasis
Being tested: CT-P43, Stelara
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P43Biological
45mg or 90mg dose subcutaneous administration
StelaraBiological
45mg or 90mg dose subcutaneous administration

Study groups in NCT04673786
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: CT-P43; Biological: Stelara

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: From baseline to Week 12

Secondary outcomes (5)

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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202112 May 2022

First posted17 Dec 2020
Study start11 Jan 2021
Primary completion4 Aug 2021
Study completion12 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04673786
Sponsor's protocol ID: CT-P43 3.1
Other IDs: 2020-001045-39
Status last verified: Jun 2023
First submitted: 13 Dec 2020
Last updated: 5 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 37991693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04673786
Acronym / sponsor ID: CT-P43 3.1
Conditions: Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 509 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 11 Jan 2021 (actual)
Primary completion: 4 Aug 2021 (actual)
Study completion: 12 May 2022 (actual)
First posted: 17 Dec 2020 (actual)
Results: Posted 5 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CT-P43	Experimental	Biological: CT-P43All 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.
Stelara	Active comparator	Biological: CT-P43, Biological: StelaraPatients 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P4345mg or 90mg dose subcutaneous administration	Biological	CT-P43, Stelara
Stelara45mg or 90mg dose subcutaneous administration	Biological	Stelara

Primary outcome

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).

5 secondary outcomes

The PASI Scores at Week 12
Time frame: Week 12
The Mean Percent Improvement From Baseline in PASI Score Through Week 52
Time frame: Through Week 52
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 Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12
Time frame: Week 12
The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52
Time frame: Through Week 52

Results and safety

Results posted to the registry on 5 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P43	256	253
EU-Stelara	253	249
Switched to CT-P43	0	0

Primary outcome: The Mean Percent Improvement From Baseline in PASI Score at Week 12

Time frame: From baseline to Week 12. Least squares mean (Standard Error). Unit: percentage of improvement in PASI score

Measure	CT-P43 n = 256	EU-Stelara n = 253
Value	77.93 (1.771)	75.89 (1.739)

CT-P43 vs EU-Stelara: Treatment difference (%) and 90% CI: 2.05 (90% CI -0.23 to 4.32), ANCOVA

Population analysed: Modified ITT Set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through 52 weeks. Other adverse events reported at 3% frequency or more

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

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37991693Papp 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.

Related trials for Psoriasis

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT-P43 and Stelara in people with Psoriasis, run by Celltrion at 1 site in Estonia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Mean Percent Improvement From Baseline in PASI Score at Week 12 (time frame: From baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673786, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.