Plaque Psoriasis
Conditions
Keywords
PsO
Brief summary
This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.
Detailed description
This is a 55-week, randomized, double-blind, active-control, parallel group, multicenter, global study in subjects with active, moderate to severe, chronic PsO. The study will consist of 24 weeks of administration of blinded study drug, divided into Treatment Period 1 and Treatment Period 2, then 23 weeks of administration of open-label CHS-1420 and a Follow-up visit 8 weeks after the last dose. Subjects who meet inclusion/exclusion criteria will be stratified by body mass index (BMI), and age and randomized 1:1 to receive CHS-1420 or Humira in Treatment Period 1. Subjects assigned to CHS-1420 will continue to receive CHS-1420 in Period 2. Subjects assigned to Humira in Period 1 will be randomly assigned (1:1) to either continue with Humira in Treatment Period 2 or to switch to CHS-1420 in Treatment Period 2. All subjects will receive open label CHS-1420 in Treatment Period 3.
Interventions
DRUGCHS-1420
DRUGAdalimumab
Sponsors
Coherus Oncology, Inc.
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female adults * PsO diagnosis for 6 months * Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5), * Body Surface Area (BSA) involved with PsO greater than or equal to 10%
Exclusion criteria
* Forms of psoriasis other than PsO * Drug induced psoriasis * Positive QuantiFERON-tuberculosis (TB) Gold Test * Presence of significant comorbid conditions * Chemistry and hematology values outside protocol specified range * Major systemic infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 | 12 weeks | The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established. |
Countries
Bulgaria, Canada, Chile, Croatia, Estonia, Georgia, Israel, Italy, Latvia, Moldova, Poland, Russia, Slovakia, South Africa, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CHS-1420 CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end.
CHS-1420 | 274 |
| Humira (Adalimumab) Reassigned to CHS-1420 Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to CHS-1420 40mg dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.
Adalimumab
CHS-1420 | 135 |
| Humira (Adalimumab) Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be reassigned (1:1) to continue adalimumab treatment, 1 dose 40mg every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420, 1 dose 40mg every 2 weeks, open label until study end.
Adalimumab
CHS-1420 | 136 |
| Total | 545 |
Baseline characteristics
| Characteristic | CHS-1420 | Humira (Adalimumab) Reassigned to CHS-1420 | Humira (Adalimumab) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 11 Participants | 9 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 256 Participants | 124 Participants | 127 Participants | 507 Participants |
| Sex: Female, Male Female | 82 Participants | 31 Participants | 38 Participants | 151 Participants |
| Sex: Female, Male Male | 192 Participants | 104 Participants | 98 Participants | 394 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 274 | 0 / 271 | 0 / 255 | 0 / 126 | 0 / 130 | 1 / 474 |
| other Total, other adverse events | 41 / 274 | 38 / 271 | 0 / 255 | 0 / 126 | 0 / 130 | 0 / 474 |
| serious Total, serious adverse events | 4 / 274 | 6 / 271 | 4 / 255 | 3 / 126 | 1 / 130 | 4 / 474 |
Outcome results
Primary
Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12
The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Humira (Adalimumab) | Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 | 203 Participants |
| CHS-1420 | Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 | 211 Participants |