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Plaque Type PsoriasisPhase 3ADACCESSNCT02016105

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

A Phase 3 study testing GP2017 Adalimumab and Humira ® Adalimumab in people with Plaque Type Psoriasis, run by Sandoz at 79 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Type Psoriasis
What is being tested?
GP2017 Adalimumab and Humira ® Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
465 participants
Where
79 sitesin 4 countries
Study dates
Dec 2013to Feb 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

79 sites in 4 countries.

79 sites in 4 countries

United States69 sites

  • Anaheim Clinical Trials

    Anaheim, California

  • Austin Dermatology Associates

    Austin, Texas, 78705

  • Bakersfield Dermatology and Skin Cancer Medical Group

    Bakersfield, California

  • Medical Development Centers, LLC

    Baton Rouge, Louisiana, 70808

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Wallace Medical Group

    Beverly Hills, California, 90211

  • Total Skin & Beauty Dermatology Center

    Birmingham, Alabama

  • PMG Research of Bristol, LLC

    Bristol, Tennessee, 37620

  • Buffalo Medical Group, P.C.

    Buffalo, New York

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina

  • Mountain State Clinical Research

    Clarksburg, West Virginia

  • Ohio State University Clinical Trials Management Office

    Columbus, Ohio

  • Florida Academic Dermatology Center

    Coral Gables, Florida

  • Corvallis Clinic PC

    Corvallis, Oregon, 97330

  • Menter Dermatology Research Institute

    Dallas, Texas

  • Modern Research Associates

    Dallas, Texas

  • Horizons Clinical Research Center, LLC

    Denver, Colorado, 80220

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

  • Forest Hills Dermatology Group

    Forest Hills, New York, 11375

  • Associated Skin Care Specs

    Fridley, Minnesota

  • Radiant Research, Inc.

    Greer, South Carolina

  • J. Woodson Dermatology & Associates

    Henderson, Nevada

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46256

  • Clinical Partners, LLC

    Johnston, Rhode Island

  • Dermat. & Adv. Aesthetics

    Lake Charles, Louisiana

  • New York University Medical

    Lake Success, New York, 11041

  • Las Vegas Skin and Cancer Clinic

    Las Vegas, Nevada, 89128

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Dr. Howard Sofen

    Los Angeles, California

  • Southern California Permanente Medical Group

    Los Angeles, California

  • Dermatology Specialists Research, LLC

    Louisville, Kentucky, 40202

  • DermResearch, PLLC

    Louisville, Kentucky

  • Florida Medical Center & Research Inc

    Miami, Florida

  • Clinical Trials of America, Inc.

    Monroe, Louisiana

  • The Dermatology Center, PSC

    New Albany, Indiana, 47150

  • Savin Dermatology Center, P.C.

    New Haven, Connecticut

  • MedPhase, Inc.

    Newnan, Georgia, 30263

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Advanced Research Institute

    Ogden, Utah

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Pedia Research, LLC

    Owensboro, Kentucky

  • Psoriasis Treatment Center of South Florida

    Pembroke Pines, Florida, 33028

  • Alliance Dermatology & MOHS Center, PC

    Phoenix, Arizona, 85032

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15213

  • The Indiana Clinical Trials Center

    Plainfield, Indiana

  • Oregon Dermatology and Research Center

    Portland, Oregon, 97210

  • Oregon Medical Research Center, P.C.

    Portland, Oregon, 97223

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Palmtree Clinical Research

    Rancho Mirage, California, 92270

  • Health Concepts

    Rapid City, South Dakota

  • Pharmaceutical Research Organization

    Rigby, Idaho

  • MediSearch Clinical Trials

    Saint Joseph, Missouri

  • Stephen Miller MD

    San Antonio, Texas, 78249

  • Medical Center For Clinical Research

    San Diego, California

  • Therapeutics Clinical Research

    San Diego, California

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Premier Clinical Research

    Spokane, Washington

  • Central Dermatology

    St Louis, Missouri, 63117

  • The Clinical Research Center, L.L.C.

    St Louis, Missouri

  • DermResearch Center of New York

    Stony Brook, New York

  • McIlwain Medical Group, PA

    Tampa, Florida, 33613

  • Somerset Skin Centre

    Troy, Michigan

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts

  • Center for Clinical Studies

    Webster, Texas

  • Dundee Derm.

    West Dundee, Illinois

  • Wilmington Dermatology Center

    Wilmington, North Carolina, 28403

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina

Other trials in United States

Bulgaria4 sites

  • UMHAT Dr. Georgi Stranski, EAD

    Pleven

  • Center for Skin and Venereal Diseases EOOD Sofia

    Sofia

  • UMHAT "Alexandrovska", EAD

    Sofia

  • Diagnostic-consulting center 3-Varna EOOD

    Varna

Other trials in Bulgaria

Slovakia4 sites

  • Pedi-Derma s.r.o., Dermatovenerologicka ambulancia

    Košice

  • Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc

    Kosice-Saca

  • SANARE s.r.o. Dermatovenerologická ambulancia

    Svidník, 08901

  • SANARE s.r.o.

    Svidník

Other trials in Slovakia

France2 sites

  • Hopital de l'Archet 2

    Nice

  • Hôpital Charles Nicolle

    Rouen

Other trials in France

About this study

Official title: A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

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.

Read the 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.

Being tested
GP2017 Adalimumab, Humira ® Adalimumab
Keywords
plaque type psoriasis, equivalent efficacy, safety and immunogenicity, GP2017, Humira®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GP2017 AdalimumabDrug

  • Humira ® AdalimumabDrug

Study groups in NCT02016105
Study groupRoleWhat they receive
GP2017 AdalimumabExperimentalStudy 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.
Receives: Drug: GP2017 Adalimumab
Humira ® AdalimumabActive comparatorHumira® 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.
Receives: Drug: Humira ® Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab

    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.

    Measured: At Week 16 only

Secondary outcomes (13)

  1. Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)

    The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.

    Measured: Baseline to Week 16

  2. Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)

    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).

    Measured: Baseline to Week 16

  3. PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates

    Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)

    Measured: At Week 17 only

  4. PASI 50, PASI75, PASI 90 and PASI100 Response Rates

    Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)

    Measured: At Week 35 only

  5. PASI 50, PASI75, PASI 90 and PASI100 Response Rates

    Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)

    Measured: At Week 51 only

  6. IGA Response Rate

    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 17.

    Measured: At Week 17 only

  7. IGA Response Rate

    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

    Measured: At Week 35 only

  8. IGA Response Rate

    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

    Measured: At Week 51 only

  9. DLQI

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

    Measured: At Week 17 only

  10. DLQI

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

    Measured: At Week 35 only

  11. DLQI

    Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)

    Measured: At Week 51 only

  12. ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17

    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.

    Measured: At Week 17 only

  13. ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51

    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.

    Measured: At Week 51 only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJul 2015
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
465 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02016105
Sponsor's protocol ID
GP17-301
Other IDs
2013-000747-11
Acronym
ADACCESS
Status last verified
Apr 2017
First submitted
14 Dec 2013
Last updated
30 May 2017
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Betteridge N, Blauvelt A, Edgerton C, Fan J, Guerrieri D, Rose L, Brueckmann I, Wang Q. Comparison of treatment with GP2017 (an adalimumab biosimilar) and reference adalimumab in people with plaque psoriasis: a plain language summary of the ADACCESS trial. Immunotherapy. 2026 Jan;18(1):5-15. doi: 10.1080/1750743X.2026.2624291. Epub 2026 Feb 18.

    PubMed 41709696

  • Lemke L, Blauvelt A, Bruckmann I, Cohen HP, Fan J, Guerrieri D, Horvat M, Poetzl J, Torella C, Wang Q, von Richter O. Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. Expert Opin Biol Ther. 2024 Dec;24(12):1375-1385. doi: 10.1080/14712598.2024.2428299. Epub 2024 Nov 19.

    PubMed 39545451

  • Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2.

    PubMed 33651341

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP2017 Adalimumab and Humira ® Adalimumab in people with Plaque Type Psoriasis, run by Sandoz at 79 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Bulgaria, Slovakia, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab (time frame: At Week 16 only). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02016105, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 30 Oct 2026.

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