Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 December 2019 |
Main ID: |
EUCTR2015-000632-15-SK |
Date of registration:
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07/07/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study to compare the efficacy and safety of CHS-1420 against Humira®
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Scientific title:
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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 (PsOsim) |
Date of first enrolment:
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26/08/2015 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000632-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Double blind plus an open label extention (treatment period 3)
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Armenia
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Belarus
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Bulgaria
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Canada
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Chile
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Croatia
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Estonia
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Georgia
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Hungary
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Israel
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Italy
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Latvia
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Lebanon
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Macedonia, the former Yugoslav Republic of
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Mexico
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Moldova, Republic of
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Poland
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Russian Federation
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Serbia
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Slovakia
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South Africa
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Jennifer Hodge
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Address:
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333 Twin Dolphin Drive - Suite 600
CA 94065
Redwood City
United States |
Telephone:
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001650649-3530 |
Email:
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Affiliation:
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Coherus BioSciences, Inc. |
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Name:
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Jennifer Hodge
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Address:
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333 Twin Dolphin Drive - Suite 600
CA 94065
Redwood City
United States |
Telephone:
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001650649-3530 |
Email:
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Affiliation:
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Coherus BioSciences, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female adult at least 18 years of age;
2. Diagnosis of chronic plaque-type psoriasis at least 6 months prior to Screening;
3. Moderate to severe chronic plaque type psoriasis as defined at Screening by:
1. PASI score of greater than or equal to 12,
2. Physician’s Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0 to 5), and
3. Body surface area affected by chronic plaque-type psoriasis of greater than or equal to 10%;
4. Considered a candidate by the Investigator to start anti-TNF therapy for PsO; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria: 1. Forms of psoriasis other than chronic PsO (e.g., pustular erythrodermic, guttate psoriasis);
2. Previous receipt of anti-TNF therapies (and biosimilars to anti-TNF-therapies) for any indication at any time, including infliximab, (Remicade) etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), certolizumab pegol (Cimzia), pentoxifyllene (Trental);
3. Initiation of a drug that is known to cause or exacerbate psoriasis (including, but not limited to, beta-blockers, lithium, and anti-malarials), within the 6 months prior to Randomization (Week 0/Day 0); those who have been on a stable dose for at least 6 months prior to Randomization (Week 0/Day 0) without exacerbation of psoriasis may be enrolled and do not need to discontinue these medications;
4. Receipt of an investigational drug or investigational device study within the 28 days prior to Randomization (Week 0/Day 0) or a period equal to 5 times the half-life of the investigational agent (whichever is longer);
5. History of alcohol or drug abuse within 2 years prior to Screening;
6. Diagnosis of rheumatic disease, autoimmune disease, connective tissue disease, or immune deficiency disease (e.g., primary Sjögren’s syndrome, systemic lupus erythematosus, demyelinating diseases such as multiple sclerosis); Note: Psoriatic arthritis is allowed.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Chronic Plaque Psoriasis
MedDRA version: 18.1
Level: LLT
Classification code 10071117
Term: Plaque psoriasis
System Organ Class: 100000004858
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Intervention(s)
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Product Name: adalimumab (CHS-1420) Product Code: CHS-1420 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: CHS-1420 Other descriptive name: CHS-1420 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-
Trade Name: Humira Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: Humira Other descriptive name: Humira Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-
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Primary Outcome(s)
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Primary end point(s): 75% improvement in Psoriasis Area and Severity Index (PASI-75)
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Secondary Objective: The secondary objectives are to compare the safety of and response to CHS-1420 and Humira over 24 weeks as well as efficacy/safety of switching from Humira to CHS-1420. To assess long term safety and efficacy of CHS-1420 during the open label extension over a further 24 weeks (Treatment Period 3)
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Timepoint(s) of evaluation of this end point: At Week 12 relative to baseline, where baseline will be the last assessment prior to beginning study drug (scheduled for Week 0/day 0).
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Main Objective: The primary objective of this study is to compare the efficacy (measured by the Psoriasis Area and Severity Index [PASI]) and safety of CHS-1420 and Humira at 12 weeks in subjects with moderate to severe chronic PsO.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. at Weeks 2, 4, 6, 8, 10, 16, 20, and 24, 32, 40 and 48;
2. from Baseline at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24, 32, 40 and 48;
3. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24, 32, 40 and 48;
4. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24, 32, 40 and 48;
5. from Baseline to Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48; and, as applicable, the Follow-up or ET visit;
6. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40 and 48 and, as applicable, the Follow-up or ET visit;
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Secondary end point(s): 1. PASI-75
2. Percentage changes in PASI
3. 50% improvement in Psoriasis Area and Severity Index (PASI-50)
4. 90% improvement in Psoriasis Area and Severity Index (PASI-90)
5. Changes in PSGA of disease activity on a scale from 0 to 5
6. Change in PSGA = 0 to 1, demonstrating clear or almost clear skin
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Secondary ID(s)
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CHS-1420-02
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119540
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2015-000632-15-LV
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Source(s) of Monetary Support
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Coherus BioSciences, Inc.
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Ethics review
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Status: Approved
Approval date:
Contact:
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