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Trial record 1 of 1 for:
CHS 1420
Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (PsOsim)
This study has been completed.
Sponsor:
Coherus Biosciences, Inc.
Information provided by (Responsible Party):
Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT02489227
First received: July 1, 2015
Last updated: June 9, 2017
Last verified: June 2017
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Purpose
This is a 3-part study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.
| Condition | Intervention | Phase |
|---|---|---|
| Plaque Psoriasis | Drug: CHS-1420 Drug: Adalimumab | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis |
Resource links provided by NLM:
Further study details as provided by Coherus Biosciences, Inc.:
Primary Outcome Measures:
- 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 [ Time Frame: 12 weeks ]
| Enrollment: | 545 |
| Study Start Date: | August 2015 |
| Study Completion Date: | March 2017 |
| Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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 CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. At week 24 subjects will switch to CHS-1420 open label until study end.
|
Drug: CHS-1420
Drug: Adalimumab
Other Name: Humira
|
|
Experimental: 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.
|
Drug: CHS-1420 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02489227
Please refer to this study by its ClinicalTrials.gov identifier: NCT02489227
Locations
| United States, Missouri | |
| Central Dermatology | |
| Saint Louis, Missouri, United States, 63117 | |
Sponsors and Collaborators
Coherus Biosciences, Inc.
Investigators
| Study Director: | Barbara K Finck, M.D. | Coherus Biosciences, Inc. |
More Information
| Responsible Party: | Coherus Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT02489227 History of Changes |
| Other Study ID Numbers: |
CHS-1420-02 |
| Study First Received: | July 1, 2015 |
| Last Updated: | June 9, 2017 |
Keywords provided by Coherus Biosciences, Inc.:
|
PsO |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on July 17, 2017