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Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (PsOsim)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489227
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : October 18, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: CHS-1420
Drug: Adalimumab
Enrollment 545
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CHS-1420 Humira (Adalimumab) Reassigned to CHS-1420 Humira (Adalimumab)
Hide Arm/Group Description

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

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.open label until study end.

Adalimumab

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 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

Period Title: Overall Study
Started 274 135 136
Completed 220 101 117
Not Completed 54 34 19
Arm/Group Title CHS-1420 Humira (Adalimumab) Reassigned to CHS-1420 Humira (Adalimumab) Total
Hide Arm/Group Description

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 274 135 136 545
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 135 participants 136 participants 545 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
256
  93.4%
124
  91.9%
127
  93.4%
507
  93.0%
>=65 years
18
   6.6%
11
   8.1%
9
   6.6%
38
   7.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 135 participants 136 participants 545 participants
Female 82 31 38 151
Male 192 104 98 394
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira (Adalimumab) CHS-1420
Hide Arm/Group Description:

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.

CHS-1420

Adalimumab

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

Overall Number of Participants Analyzed 271 274
Measure Type: Count of Participants
Unit of Measure: Participants
203
  74.9%
211
  77.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Period 1: CHS-1420 Treatment Period 1: Humira (Adalimumab) Treatment Period 2: CHS-1420/CHS-1420 Treatment Period 2: Humira/CHS-1420 Teatment Period 2: Humira/Humira Treatment Period 3: Open Label CHS-1420 Extension
Hide Arm/Group Description CHS-1420 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15 Adalimumab (Humira) 40mg, 2 doses at Week 0/Day 0 then 40 mg, 1 dose every 2 weeks starting at Week 1 until Week 15. At week 16 subjects initially randomized to CHS-1420 will continue CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24 At Week 16 subjects initially randomized to Humira (adalimumab) will be reassigned to CHS-1420 treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24 At Week 16 subjects initially randomized to Humira (adalimumab) will continue adalimumab treatment 40 mg, 1 dose every 2 weeks starting at Week 16 to Week 24 At week 24 all subjects will switch to CHS-1420 treatment 40 mg, 1 dose every 2 weeks, open label, starting at week 24 until study end
All-Cause Mortality
Treatment Period 1: CHS-1420 Treatment Period 1: Humira (Adalimumab) Treatment Period 2: CHS-1420/CHS-1420 Treatment Period 2: Humira/CHS-1420 Teatment Period 2: Humira/Humira Treatment Period 3: Open Label CHS-1420 Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/274 (0.00%)      0/271 (0.00%)      0/255 (0.00%)      0/126 (0.00%)      0/130 (0.00%)      1/474 (0.21%)    
Hide Serious Adverse Events
Treatment Period 1: CHS-1420 Treatment Period 1: Humira (Adalimumab) Treatment Period 2: CHS-1420/CHS-1420 Treatment Period 2: Humira/CHS-1420 Teatment Period 2: Humira/Humira Treatment Period 3: Open Label CHS-1420 Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/274 (1.46%)      6/271 (2.21%)      4/255 (1.57%)      3/126 (2.38%)      1/130 (0.77%)      4/474 (0.84%)    
Cardiac disorders             
Acute Myocardial Infarction  1/274 (0.36%)  1 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Congenital, familial and genetic disorders             
Congenital Cystic kidney disease  0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 1/474 (0.21%)  1
Gastrointestinal disorders             
Diarrhea  0/274 (0.00%)  0 1/271 (0.37%)  1 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Anal fistula  0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 1/126 (0.79%)  1 0/130 (0.00%)  0 0/474 (0.00%)  0
Gastritis  0/274 (0.00%)  0 0/271 (0.00%)  0 1/255 (0.39%)  1 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Inguinal Hernia  0/274 (0.00%)  0 0/271 (0.00%)  0 1/255 (0.39%)  1 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Infections and infestations             
Gastroenteritis  0/274 (0.00%)  0 1/271 (0.37%)  1 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Pneumonia  0/274 (0.00%)  0 1/271 (0.37%)  1 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 1/474 (0.21%)  1
Sinusitis  0/274 (0.00%)  0 1/271 (0.37%)  1 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Bronchitis  0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 1/126 (0.79%)  1 0/130 (0.00%)  0 0/474 (0.00%)  0
Lobar pneumonia  0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 1/126 (0.79%)  1 0/130 (0.00%)  0 0/474 (0.00%)  0
Tuberculosis  0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 1/130 (0.77%)  1 0/474 (0.00%)  0
Injury, poisoning and procedural complications             
Foot Fracture  0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Limb injury  0/274 (0.00%)  0 0/271 (0.00%)  0 1/255 (0.39%)  1 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Metabolism and nutrition disorders             
Dehydration  0/274 (0.00%)  0 1/271 (0.37%)  1 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Diabetic Ketoacidosis  0/274 (0.00%)  0 1/271 (0.37%)  1 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Obesity  0/274 (0.00%)  0 0/271 (0.00%)  0 1/255 (0.39%)  1 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Psoriatic arthropathy  1/274 (0.36%)  1 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Rotator cuff syndrome  1/274 (0.36%)  1 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Glioblastoma multiforme   0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 1/474 (0.21%)  1
Renal and urinary disorders             
Calculus ureteric   0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 1/126 (0.79%)  1 0/130 (0.00%)  0 0/474 (0.00%)  0
Renal failure chronic   0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 1/474 (0.21%)  1
Respiratory, thoracic and mediastinal disorders             
Chronic and obstructive pulmonary disease  0/274 (0.00%)  0 1/271 (0.37%)  1 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Skin and subcutaneous tissue disorders             
Psoriasis  1/274 (0.36%)  1 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Vascular disorders             
shock   0/274 (0.00%)  0 0/271 (0.00%)  0 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 1/474 (0.21%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Period 1: CHS-1420 Treatment Period 1: Humira (Adalimumab) Treatment Period 2: CHS-1420/CHS-1420 Treatment Period 2: Humira/CHS-1420 Teatment Period 2: Humira/Humira Treatment Period 3: Open Label CHS-1420 Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/274 (14.96%)      38/271 (14.02%)      0/255 (0.00%)      0/126 (0.00%)      0/130 (0.00%)      0/474 (0.00%)    
Infections and infestations             
Nasopharyngitis  24/274 (8.76%)  24 24/271 (8.86%)  24 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Upper respiratory tract infection   17/274 (6.20%)  17 14/271 (5.17%)  14 0/255 (0.00%)  0 0/126 (0.00%)  0 0/130 (0.00%)  0 0/474 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Darlene P. Horton
Organization: Coherus BioSciences, Inc.
Phone: 650-395-3529
EMail: dhorton@coherus.com
Layout table for additonal information
Responsible Party: Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02489227    
Other Study ID Numbers: CHS-1420-02
First Submitted: July 1, 2015
First Posted: July 2, 2015
Results First Submitted: July 3, 2019
Results First Posted: October 18, 2019
Last Update Posted: February 13, 2020