Coherus Open-Label Safety Extension Study

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2015-000665-30-DE
• Date of registration: 14/07/2015
• Prospective Registration: Yes
• Primary sponsor: Coherus BioSciences, Inc.
• Public title: Coherus Open-Label Safety Extension Study
• Scientific title: An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES
• Date of first enrolment: 17/12/2015
• Target sample size: 447
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000665-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Canada, France, Germany, Israel, Italy, Japan, South Africa, Spain, United Kingdom

Contacts

• Name: Director of Regulatory Submissions
• Affiliation: Medpace UK

• Name: Director of Regulatory Submissions
• Affiliation: Medpace UK

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have completed 48 weeks of evaluations in CHS 0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS 0214-04 and, at Week 48, had at least a PASI-50;
2. Women who either:
a) Are of childbearing potential with a negative urine pregnancy test at
Week 0 Day 0 who agree to use 1 or more approved methods of birth
control (hormonal contraception, intrauterine device, diaphragm plus
spermicide, condom plus spermicide, or abstinence from heterosexual
intercourse—abstinence from heterosexual intercourse will be
acceptable only if it is the preferred and usual lifestyle of the subject
regardless of study participation; abstinence should be practiced for the
duration of the study Follow-up Visit 28 days after the last dose of study
drug);
b) Have been postmenopausal for at least 2 years (with amenorrhea for at least 1 year) or have had a hysterectomy, bilateral salpingo oophorectomy, or tubal ligation prior to signing the informed consent; and
3. Able and willing to give written informed consent prior to performance of any study related procedures.
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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

Exclusion criteria:
1. Men whose partners may become pregnant (do not agree to use contraception or who are not postmenopausal) or who may breastfeed during the study (Japan only specific exclusion).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Rheumatoid arthritis Chronic Plaque Psoriasis
MedDRA version: 19.0 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859
MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Intervention(s)

Product Code: CHS-0214
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Current Sponsor code: CHS-0214
Other descriptive name: BGX-0214
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): SAFETY: Safety will be assessed by:
• Assessment of treatment-emergent AEs;
• Determination of subject withdrawal information;
• Assessment of injection site reactions;
• Assessment of changes in safety laboratory parameters, including hematology, clinical chemistry, and pregnancy tests;
• Assessment of changes in vital signs, physical examination, and electrocardiogram findings;
• Monitoring for tuberculosis (TB) with regular QuantiFERON®-TB Gold test (every 12 months or more frequently for regions with high incidences of TB or to evaluate signs and symptoms that might be due to TB); and
• Assessment of immunogenicity (anti-CHS 0214 antibodies)

EFFICACY: Durability of response will be measured as follows:
• For subjects with RA, maintenance of an ACR20 response or greater
• For subjects with PsO, maintenance of PASI-50 response or greater

Main Objective: To evaluate the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS 0214-04, evaluating CHS 0214 in rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.

Timepoint(s) of evaluation of this end point: SAFTEY: At 1 month and 3 months following enrollment and every 3 months thereafter
EFFICACY: At each visit

Secondary Objective: N/A

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: EFFICACY: At all visits.
Retained Samples: Up to 2 years after completion of the study (data base lock).

Secondary end point(s): EFFICACY: For subjects with RA, Disease Activity Score using 28 tender
and swollen joint counts, high sensitivity C reactive protein, and
subject's global assessment (DAS28-CRP [4]) to < 3.2 (low disease
activity) assessed at all visits and < 2.6 (remission) assessed on all
visits after DAS28-CRP (4) < 2.6 is achieved

Retained Samples:
Serum samples will be collected at each visit and retained for potential analysis of serum concentration of CHS 0214, anti-drug antibodies, or other tests as necessary to evaluate AEs, loss of response, or compliance. Serum samples will not be used to assess population pharmacokinetics (PK), biomarkers, or genetics. Samples will be stored at Medpace Reference Laboratory, LLC (MRL) and may be transferred to Charles River Laboratories or other reference laboratory for analysis at the request of the Sponsor. All retained samples and remnants of samples will be destroyed 2 years after the completion of the study (data base lock).

Secondary ID(s)

2015-000665-30-GB

115,675

CHS-0214-05

Source(s) of Monetary Support

Baxter Healthcare SA

Baxter International Inc.

Coherus Biosciences Inc.

Baxter Healthcare Corporation

Daiichi Sankyo Company Ltd.