A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis

Study Purpose

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants has moderate to severe plaque psoriasis (with or without psoriatic arthritis) for at least 6 months and has stable disease for at least 2 months.
  • - Participants has a score of PASI ≥ 12, involvement of ≥ 10% body surface area (BSA) and static Physician's Global Assessment (sPGA) ≥ 3 at screening and at baseline.
  • - Participant has no known history of latent or active tuberculosis.

Exclusion Criteria:

  • - Participant has erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication induced psoriasis, or other skin conditions at the time of screening (eg, eczema) that would interfere with evaluations of the effect of investigational product of psoriasis.
  • - Participant has an active infection or history of infections.
  • - Participant has received biologic treatment for psoriasis within the previous month or 5 drug half-lives (whichever is longer) prior to enrollment.
  • - Participant has received nonbiologic systemic psoriasis therapy within 4 weeks prior to enrollment.
  • - Participant has received ultraviolet (UV) A phototherapy (with or without psoralen) or excimer laser within 4 weeks prior to enrollment, or UV B phototherapy within 2 weeks prior to enrollment.
- Participant has received topical psoriasis treatment within 2 weeks prior to enrollment

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05073315
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Active Comparator: Continued-use Group (Adalimumab)

Randomized participants will receive continuous injection of adalimumab Q2W until last dose at Week 28.

Experimental: Switching Group (Adalimumab - ABP 501)

Participants will initially receive adalimumab until Week 10 during the lead-in period. Thereafter, starting from Week 12, participants will switch between ABP 501 and adalimumab Q2W with last dose of ABP 501 at Week 28.

Interventions

Drug: - Adalimumab

Participants will receive subcutaneous (SC) injection of adalimumab

Drug: - ABP 501

Participants will receive SC injection of ABP 501

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dermatology Research Associates, Los Angeles, California

Status

Recruiting

Address

Dermatology Research Associates

Los Angeles, California, 90045

Unison Clinical Trials, Sherman Oaks, California

Status

Recruiting

Address

Unison Clinical Trials

Sherman Oaks, California, 91403

Revival Research, Doral, Florida

Status

Recruiting

Address

Revival Research

Doral, Florida, 33122

Georgia Skin and Cancer Clinic - Clinic, Savannah, Georgia

Status

Recruiting

Address

Georgia Skin and Cancer Clinic - Clinic

Savannah, Georgia, 31419

Metro Boston Clinical Partners, Brighton, Massachusetts

Status

Recruiting

Address

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135

Skin Search of Rochester, Inc., Rochester, New York

Status

Recruiting

Address

Skin Search of Rochester, Inc.

Rochester, New York, 14623

Wilmington Dermatology Center, Wilmington, North Carolina

Status

Recruiting

Address

Wilmington Dermatology Center

Wilmington, North Carolina, 28405

Charleston, South Carolina

Status

Recruiting

Address

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407

Murfreesboro, Tennessee

Status

Recruiting

Address

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130

Houston, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research - Dermatology

Houston, Texas, 77056

Laredo, Texas

Status

Recruiting

Address

Cutis Wellness Dermatology & Dermapathology, PLLC

Laredo, Texas, 78041

Progressive Clinical Research [Texas], San Antonio, Texas

Status

Recruiting

Address

Progressive Clinical Research [Texas]

San Antonio, Texas, 78213

San Antonio, Texas

Status

Recruiting

Address

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229

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