Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

Phase 3

Completed

Conditions: Plaque Type Psoriasis

Interventions: Drug: GP2017 Adalimumab
Drug: Humira ® Adalimumab

Registration Number: NCT02016105

Lead Sponsor: Sandoz

Brief Summary: The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Detailed Description: The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 465

Inclusion Criteria

Men or women at least 18 years of age at time of screening
Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
Moderate to severe psoriasis as defined at baseline by:
- PASI score of 12 or greater
- Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
- Body Surface Area affected by plaque-type psoriasis of 10% or greater
Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.

Exclusion Criteria

Forms of psoriasis other than chronic plaque-type
Drug-induced psoriasis
Ongoing use of prohibited psoriasis treatments
Previous exposure to adalimumab
Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab

Other In-/Exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP2017 Adalimumab	GP2017 Adalimumab	Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.
Humira ® Adalimumab	Humira ® Adalimumab	Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

Primary Outcome Measures

Name	Time	Method
PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab	At Week 16 only	The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)	Baseline to Week 16	The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.
PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates	At Week 17 only	Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)
Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)	Baseline to Week 16	The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).
DLQI	At Week 51 only	Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
PASI 50, PASI75, PASI 90 and PASI100 Response Rates	At Week 51 only	Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51	At Week 51 only	Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51. Patients with ADA positive results at baseline were excluded from subsequent results.
IGA Response Rate	At Week 51 only	Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51
ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17	At Week 17 only	Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17. Patients with ADA positive results at baseline were excluded from subsequent results.

Trial Locations

Locations (79): Total Skin & Beauty Dermatology Center
🇺🇸
Birmingham, Alabama, United States
Alliance Dermatology & MOHS Center, PC
🇺🇸
Phoenix, Arizona, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Anaheim Clinical Trials
🇺🇸
Anaheim, California, United States
Bakersfield Dermatology and Skin Cancer Medical Group
🇺🇸
Bakersfield, California, United States
Wallace Medical Group
🇺🇸
Beverly Hills, California, United States
California Dermatology & Clinical Research Institute
🇺🇸
Encinitas, California, United States
Dr. Howard Sofen
🇺🇸
Los Angeles, California, United States
Southern California Permanente Medical Group
🇺🇸
Los Angeles, California, United States
Palmtree Clinical Research
🇺🇸
Rancho Mirage, California, United States
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Total Skin & Beauty Dermatology Center
🇺🇸Birmingham, Alabama, United States