A study to compare the efficacy and safety of CHS-1420 against Humira®

• Register: EUCTR
• Last refreshed on: 22 May 2017
• Main ID: EUCTR2015-000632-15-LV
• Date of registration: 30/06/2015
• Prospective Registration: Yes
• Primary sponsor: Coherus BioSciences, Inc.
• Public title: A study to compare the efficacy and safety of CHS-1420 against Humira®
• Scientific 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 (PsOsim)
• Date of first enrolment: 25/09/2015
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000632-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Armenia, Belarus, Bulgaria, Canada, Chile, Croatia, Estonia, Georgia, Hungary, Israel, Italy, Latvia, Lebanon, Macedonia, the former Yugoslav Republic of, Mexico, Moldova, Republic of, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Jennifer Hodge
• Affiliation: Coherus BioSciences, Inc.

• Name: Jennifer Hodge
• Affiliation: Coherus BioSciences, Inc.

Key inclusion & exclusion criteria

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-TNFt-therapies0 for any indication in any time, including infliximab, (Remicade) etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), certolizumab pegol (Cimzia), pentoxyfyliene (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

Health Condition(s) or Problem(s) studied

Chronic Plaque Psoriasis
MedDRA version: 18.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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-

Primary Outcome(s)

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.

Primary end point(s): 75% improvement in Psoriasis Area and Severity Index (PASI-75)

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).

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).

Secondary Outcome(s)

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

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, and 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, and 24, 32, 40 and 48 and, as applicable, the Follow-up or ET visit;

Secondary ID(s)

CHS-1420-02

119540

Source(s) of Monetary Support

Coherus BioSciences, Inc.