Psoriasis
Conditions
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.
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.
Interventions
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Percent Improvement From Baseline in PASI Score at Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| The PASI Scores at Week 12 | 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). |
| The Mean Percent Improvement From Baseline in PASI Score Through Week 52 | 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). |
| The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | 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). |
| The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12 | 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. |
| The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52 | 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). |
Countries
Estonia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT-P43 Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. | 256 |
| EU-Stelara Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. | 253 |
| Total | 509 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period II (Weeks 16 to 52) | Adverse Event | 2 | 0 | 1 |
| Treatment Period II (Weeks 16 to 52) | Death | 1 | 0 | 0 |
| Treatment Period II (Weeks 16 to 52) | Lost to Follow-up | 2 | 0 | 0 |
| Treatment Period II (Weeks 16 to 52) | Withdrawal by Subject | 9 | 3 | 1 |
| Treatment Period I (Weeks 0 to 16) | Lost to Follow-up | 0 | 1 | 0 |
| Treatment Period I (Weeks 0 to 16) | Withdrawal by Subject | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | CT-P43 | Total | EU-Stelara |
|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 13 | 42.4 years STANDARD_DEVIATION 12.81 | 42.2 years STANDARD_DEVIATION 12.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 48 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 231 Participants | 461 Participants | 230 Participants |
| Region of Enrollment Estonia | 5 Participants | 11 Participants | 6 Participants |
| Region of Enrollment Poland | 189 Participants | 377 Participants | 188 Participants |
| Region of Enrollment South Korea | 25 Participants | 48 Participants | 23 Participants |
| Region of Enrollment Ukraine | 37 Participants | 73 Participants | 36 Participants |
| Sex: Female, Male Female | 95 Participants | 175 Participants | 80 Participants |
| Sex: Female, Male Male | 161 Participants | 334 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 256 | 0 / 253 | 1 / 253 | 0 / 125 | 0 / 124 |
| other Total, other adverse events | 14 / 256 | 20 / 253 | 35 / 253 | 25 / 125 | 28 / 124 |
| serious Total, serious adverse events | 4 / 256 | 4 / 253 | 5 / 253 | 3 / 125 | 2 / 124 |
Outcome results
Primary
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
Population: Modified ITT Set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CT-P43 | The Mean Percent Improvement From Baseline in PASI Score at Week 12 | 77.93 percentage of improvement in PASI score | Standard Error 1.771 |
| EU-Stelara | The Mean Percent Improvement From Baseline in PASI Score at Week 12 | 75.89 percentage of improvement in PASI score | Standard Error 1.739 |
90% CI: [-0.23, 4.32]ANCOVA
Secondary
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
Population: Modified ITT set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P43 | The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52 | -10.5 score on a scale | Standard Deviation 7.24 |
| EU-Stelara | The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52 | -8.5 score on a scale | Standard Deviation 7.17 |
| Switched to CT-P43 | The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52 | -9.2 score on a scale | Standard Deviation 6.93 |
Secondary
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
Population: Modified ITT Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P43 | The Mean Percent Improvement From Baseline in PASI Score Through Week 52 | 93.79 percentage of improvement in PASI score | Standard Deviation 11.794 |
| EU-Stelara | The Mean Percent Improvement From Baseline in PASI Score Through Week 52 | 93.39 percentage of improvement in PASI score | Standard Deviation 14.947 |
| Switched to CT-P43 | The Mean Percent Improvement From Baseline in PASI Score Through Week 52 | 91.58 percentage of improvement in PASI score | Standard Deviation 13.264 |
Secondary
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
Population: Modified ITT Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P43 | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 50 | 247 Participants |
| CT-P43 | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 75 | 212 Participants |
| CT-P43 | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 90 | 129 Participants |
| CT-P43 | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 100 | 47 Participants |
| EU-Stelara | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 100 | 48 Participants |
| EU-Stelara | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 50 | 240 Participants |
| EU-Stelara | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 90 | 127 Participants |
| EU-Stelara | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | PASI 75 | 187 Participants |
Secondary
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
Population: Modified ITT Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P43 | The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12 | 219 Participants |
| EU-Stelara | The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12 | 201 Participants |
Secondary
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
Population: Modified ITT Set (participants analysed at Week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P43 | The PASI Scores at Week 12 | 2.98 score on a scale | Standard Deviation 3.412 |
| EU-Stelara | The PASI Scores at Week 12 | 3.44 score on a scale | Standard Deviation 4.362 |