Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis

NCT01970488 | Completed Phase 3 Results DMC

• 2 other identifiers: 201202632013-000537-12
• Study Type: interventional
• Target: 350
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.

Conditions

Psoriasis

Keywords

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16

  The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis. Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).

  Baseline and Week 16

Secondary Outcomes (13)

• Percentage of Participants With a PASI 75 Response at Week 16

  Baseline and Week 16

• Percentage of Participants With a PASI 75 Response at Week 32

  Baseline and week 32

• Percentage of Participants With a PASI 75 Response at Week 50

  Baseline and week 50

• Percent Improvement From Baseline in PASI at Week 32

  Baseline and week 32

• Percent Improvement From Baseline in PASI at Week 50

  Baseline and week 50

Study Arms (2)

ABP 501

EXPERIMENTAL

Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.

Biological: ABP 501

Adalimumab

ACTIVE COMPARATOR

Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Administered by subcutaneous injection

Also known as: HUMIRA®

Adalimumab

ABP 501 BIOLOGICAL

Administered by subcutaneous injection

Also known as: Adalimumab-atto, AMJEVITA™

ABP 501

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥ 18 and ≤ 75 years of age at time of screening
• Stable moderate to severe plaque psoriasis for at least 6 months before baseline
• Moderate to severe psoriasis defined at screening and baseline by:
• Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
• No known history of active tuberculosis
• Subject is a candidate for systemic therapy or phototherapy procedures
• Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy

You may not qualify if:

• Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
• Ongoing use of prohibited treatments
• Prior use of 2 or more biologics for treatment of psoriasis
• Previous receipt of adalimumab or a biosimilar of adalimumab

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Research Site

Saint Leonards, New South Wales, 2065, Australia

Location

Research Site

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Research Site

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Related Publications (1)

• Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017 Dec;177(6):1562-1574. doi: 10.1111/bjd.15857. Epub 2017 Dec 1.

  PMID: 28755394 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab; ABP 501

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Study Start: October 18, 2013
• Primary Completion: August 14, 2014
• Study Completion: March 18, 2015
• Last Updated: April 3, 2019
• Results First Posted: December 13, 2016

Record last verified: 2019-04

Locations

HU (1); AU (1); CA (1)