Comparison of CHS-1420 Versus Humira in Subjects With Chr... | NCT02489227 | Trialant
NCT02489227
Sponsor
Coherus Oncology, Inc.
Status
Completed
Last Update Posted
Apr 8, 2020Actual
Enrollment
545Actual
Phase
Phase 3
Conditions
Plaque Psoriasis
Interventions
CHS-1420
Adalimumab
Countries
United States
Bulgaria
Canada
Chile
Croatia
Estonia
Georgia
Israel
Italy
Latvia
Moldova
Poland
Russia
Slovakia
South Africa
Ukraine
Protocol Section
Identification Module
NCT ID
NCT02489227
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CHS-1420-02
Secondary IDs
Not provided
Brief Title
Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
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
Acronym
PsOsim
Organization
Coherus Oncology, Inc.INDUSTRY
Status Module
Record Verification Date
Mar 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2015
Primary Completion Date
May 6, 2016Actual
Completion Date
Mar 2017Actual
First Submitted Date
Jul 1, 2015
First Submission Date that Met QC Criteria
Jul 1, 2015
First Posted Date
Jul 2, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 3, 2019
Results First Submitted that Met QC Criteria
Sep 26, 2019
Results First Posted Date
Oct 18, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 31, 2017
Certification/Extension First Submitted that Passed QC Review
Jun 9, 2017
Certification/Extension First Posted Date
Jun 14, 2017Actual
Last Update Submitted Date
Mar 27, 2020
Last Update Posted Date
Apr 8, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Coherus Oncology, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Plaque Psoriasis
Keywords
PsO
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
545Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Humira (adalimumab)
Active Comparator
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 assigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. The assignments for treatment sequences (Treatment Period 1 and Treatment Period 2) were made randomly at the beginning of Treatment Period 1. At week 24 subjects will switch to CHS-1420 open label until study end.
Drug: CHS-1420
Drug: Adalimumab
CHS-1420
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CHS-1420
Drug
CHS-1420
Humira (adalimumab)
Adalimumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
12 weeks
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Barbara P Finck, M.D.
Coherus Oncology, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sadra Sasha Jazayeri, MD
Phoenix
Arizona
85032
United States
Encino Research Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Wojewodzki Szpital Specjalistyczny we Wrocławiu, Oddział Dermatologiczny
Wroclaw
51-124
Poland
Altay State Medical University
Barnaul
651045
Russia
Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Public Health Department of Moscow
Moscow
109044
Russia
Moscow State University and Dentistry named after Evdokimov
Moscow
121614
Russia
Imc "Sogaz"
Saint Petersburg
191186
Russia
Olga Mikerina, MD
Saint Petersburg
195257
Russia
Alliance Biomedical Group
Saint Petersburg
94356
Russia
Clinic of Skin and Venereal Diseases of the Saratov State Medical University
Saratov
410028
Russia
DOST - Dermatovenerologicke oddelenie sanatorneho typu
SvidnÃk
089 01
Slovakia
Panorama Medical Centre, Room 136
Panorama
Cape Town
7500
South Africa
Medicross Pretoria West 1st Floor
Pretoria West
Pretoria
0183
South Africa
Zubar Fazal Ahmed Vawda. MD
Durban
4091
South Africa
The Park, Room 201, 2nd Floor
Pinelands
7405
South Africa
Synopsis Research cc
Rondebosch
7700
South Africa
Synexus Heiderberg Clinical Research Centre
Somerset West
7130
South Africa
Clinical Projects Research SA (PTY) Ltd.
Worcester
6850
South Africa
Medical Center Private Enterprise "Dzerkalo"
Dnipro
49044
Ukraine
Ivano-Frankivsk National Medical Univeristy, Dept. of Dermatology and Venereology based on Ivano-Frankivsk Regional Clinical Dermatology and Venereology Dispensary
Ivano-Frankivsk
76018
Ukraine
Municipal Healthcare Institution "Kharkiv City Dermatovenereological Dispensary #2
National Medical University named after O.O.Bohomolets, Dept. of Dermatology and Venereology based on Oleksandrivska Clinical Hospital of Kyiv City, Dept. of Dermatology
Kyiv
01601
Ukraine
National Medical University named after Danyla Galytskoho, Dept. of Family Medicine and Dermatology, Venereology based on Dept. of Dermatovenereology of the clinical Hospital of Ukrainian State Border Guard Services
Lviv
79014
Ukraine
Odesa National Medical University, Department of Dermatic and Venereologic Diseases based on Odesa Regional Dermatovenereological Dispensary
Odesa
65006
Ukraine
Municipal Institution "Rivne Regional Dermatology and Venereology Dispensary" of Rivne Regional Council
Rivne
33028
Ukraine
Municipal Institution of Ternopil Regional Council Ternopil Regional Clinical Dermatovenereological Dispensary
Ternopil
46006
Ukraine
Diagnostic and Treatment Dermatology and Gynecology Center
Uzhhorod
88000
Ukraine
Municipal Institution "Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary" of Zaporizhzhya Regional Council
Zaporizhzhya
69063
Ukraine
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
FG002
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
FG000274 subjects
FG001135 subjects
FG002136 subjects
COMPLETED
FG000220 subjects
FG001101 subjects
FG002117 subjects
NOT COMPLETED
FG00054 subjects
FG00134 subjects
FG00219 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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
BG001
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
BG002
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
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000274
BG001135
BG002136
BG003545
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00082
BG00131
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
Posted
Count of Participants
Participants
12 weeks
ID
Title
Description
OG000
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.
CHS-1420
Adalimumab
OG001
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
Units
Counts
Participants
OG000271
OG001274
Title
Denominators
Categories
Title
Measurements
OG000203
OG001211
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Treatment Period 1: CHS-1420
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
0
274
4
274
41
274
EG001
Treatment Period 1: Humira (Adalimumab)
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.
0
271
6
271
38
271
EG002
Treatment Period 2: CHS-1420/CHS-1420
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
0
255
4
255
0
255
EG003
Treatment Period 2: Humira/CHS-1420
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
0
126
3
126
0
126
EG004
Teatment Period 2: Humira/Humira
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
0
130
1
130
0
130
EG005
Treatment Period 3: Open Label CHS-1420 Extension
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
1
474
4
474
0
474
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Myocardial Infarction
Cardiac disorders
EG0001 events1 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG0030 events0 affected126 at risk
EG0040 events0 affected130 at risk
EG0050 events0 affected474 at risk
Diarrhea
Gastrointestinal disorders
EG0000 events0 affected274 at risk
EG0011 events1 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Gastroenteritis
Infections and infestations
EG0000 events0 affected274 at risk
EG0011 events1 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Pneumonia
Infections and infestations
EG0000 events0 affected274 at risk
EG0011 events1 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Sinusitis
Infections and infestations
EG0000 events0 affected274 at risk
EG0011 events1 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Dehydration
Metabolism and nutrition disorders
EG0000 events0 affected274 at risk
EG0011 events1 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
EG0000 events0 affected274 at risk
EG0011 events1 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
EG0001 events1 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
EG0001 events1 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Chronic and obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
EG0000 events0 affected274 at risk
EG0011 events1 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
EG0001 events1 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Anal fistula
Gastrointestinal disorders
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Gastritis
Gastrointestinal disorders
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0021 events1 affected255 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0021 events1 affected255 at risk
EG003
Bronchitis
Infections and infestations
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Lobar pneumonia
Infections and infestations
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Tuberculosis
Infections and infestations
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0021 events1 affected255 at risk
EG003
Obesity
Metabolism and nutrition disorders
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0021 events1 affected255 at risk
EG003
Congenital Cystic kidney disease
Congenital, familial and genetic disorders
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Calculus ureteric
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected274 at risk
EG0010 events0 affected271 at risk
EG0020 events0 affected255 at risk
EG003
Glioblastoma multiforme
Neoplasms benign, malignant and unspecified (incl cysts and polyps)