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PsoriasisPhase 3NCT02850965

Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis

A Phase 3 study testing BI 695501 and Humira in people with Psoriasis, run by Boehringer Ingelheim at 54 sites in 8 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

To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Psoriasis
What is being tested?
BI 695501 and Humira
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
54 sitesin 8 countries
Study dates
17 Aug 2016to 17 Jan 2018
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females aged >=18 to =<80 years who have a diagnosis of moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug (a self-reported diagnosis confirmed by the investigator is acceptable), and which has been stable for the last 2 months with no changes in morphology or significant flares at both Screening and Baseline (Randomization):
  • involved body surface area (BSA) >= 10% and
  • Psoriasis Area and Severity Index (PASI) score >= 12 and
  • static Physician's Global Assessment (sPGA) score of >= 3.
  • Participants of reproductive potential (childbearing potential ) must be willing and able to use highly effective methods of birth control per International Council for Harmonization (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly during the trial and for 6 months following completion or discontinuation from the trial medication.
  • Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
  • Patients who are candidates for systemic therapy.

Who cannot join

  • Active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment.
  • Previous treatment with more than 1 biological agent, or adalimumab or adalimumab biosimilar. No prior biologic exposure within last 6 months of screening.
  • Patients with a significant disease other than psoriasis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, hematological, autoimmune or gastrointestinal disorders).
  • Major surgery performed within 12 weeks prior to randomization or planned within 6 months after screening, e.g., total hip replacement.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Show all 24Show fewer
  • Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
  • Chronic alcohol or drug abuse
  • Women who are pregnant, nursing, or who plan to become pregnant during the course of this study or within the period at least 6 months following completion or discontinuation from the trial.
  • Forms of psoriasis (e.g., pustular, erythrodermic and guttate) other than chronic plaque psoriasis. Drug-induced psoriasis (i.e., new onset or current exacerbation from e.g., beta blockers or lithium).
  • Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection or a positive HIV test at screening (per the investigator discretion and where mandated by local authorities).
  • Known chronic or relevant acute tuberculosis; no evidence of active tuberculosis.
  • Known clinically significant coronary artery disease, significant cardiac arrhythmias, moderate to severe congestive heart failure (New York Heart Association Classes III or IV) or interstitial lung disease observed on chest X-ray.
  • History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a previously used biological drug or its excipients.
  • Positive serology for hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit; patients who are expecting to receive any live/attenuated virus or bacterial vaccinations during the trial or up to 3 months after the last dose of trial drug.
  • Any treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
  • Known active infection of any kind (excluding fungal infections of nail beds), any major episode of infection requiring hospitalization or treatment with intravenous (i.v.) anti infectives within 4 weeks of the Screening Visit
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) at Screening.
  • Hemoglobin < 8.0 g/dL at Screening.
  • Platelets < 100,000/µL at Screening.
  • Leukocyte count < 4000/µL at Screening.
  • Creatinine clearance < 60 mL/min/1.73 m2 at Screening.
  • Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins, or natural rubber and latex, including serious allergic reactions.

Trial locations and contacts

54 sites in 8 countries.

54 sites in 8 countries

United States14 sites

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Advanced Clinical Research

    Boise, Idaho, 83642

  • Medical Research South

    Charleston, South Carolina, 29407

  • Menter Dermatology Research Institute

    Dallas, Texas, 75246

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Altoona Center for Clinical Research, P.C.

    Duncansville, Pennsylvania, 16635

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • New Horizon Research Center

    Miami, Florida, 33175

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Alliance Dermatology and MOHS Center PC

    Phoenix, Arizona, 85032

  • Southern California Dermatology Inc.

    Santa Ana, California, 92701

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

Poland11 sites

  • NZOZ Specderm, Bialystok

    Bialystok, 15-017

  • ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok

    Bialystok, 15-879

  • NSZOZ Unica CR, Dabrowka

    Dąbrówka, 62-069

  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

    Gdansk, 80-382

  • University Clinical Center, Gdansk

    Gdansk, 80-952

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia

    Gdynia, 81-384

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice

    Katowice, 40-040

  • SOLUMED Centrum Medyczne, Poznan

    Poznan, 60-529

  • Laser Clin. S.C. Dr T. Kochanowski Dr A. Krolicki, Szczecin

    Szczecin, 70-332

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa

    Warsaw, 01-192

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw

    Wroclaw, 50-088

Other trials in Poland

Russia8 sites

  • State Medical University, Kazan

    Kazan', 420012

  • LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

    Saint Petersburg, 190123

  • Dermatovenereological Dispensary #10, St. Petersburg

    Saint Petersburg, 194021

  • ArsVitae NorthWest LLC

    Saint Petersburg, 194223

  • EKO-Bezopasnost, St. Petersburg

    Saint Petersburg, 196143

  • 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

    Saint Petersburg, 197022

  • Institution of Healthcare "Nikolaevskaya Hospital"

    Saint Petersburg, 198510

  • Smolensk State Medical University, Smolensk

    Smolensk, 214019

Other trials in Russia

Czechia6 sites

  • Dorothea

    Chomutov, 43004

  • MU Dr. Helena Korandova s.r.o., Olomouc-Povel

    Olomouc-Povel, 779 00

  • University Hospital Ostrava

    Ostrava, 708 52

  • HOMEA spol. s.r.o., Pardubice

    Pardubice, 530 02

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 34

  • MU Dr. Jaroslav Dragon, Ústí nad Labem

    Ústí nad Labem, 400 10

Other trials in Czechia

Ukraine6 sites

  • Territorial Medical Association Dermatovenerology, Kyiv

    Kyiv, 01032

  • CH of State Border Service of Ukraine, Lviv

    Lviv, 79014

  • CI Odesa Regional Dermatovenerologic Dispensary, Odesa

    Odesa, 65006

  • CI RC Dermatovenerologic Dispensary, Ivano-Frankivsk

    Saint Ivano-Frankivsk, 76018

  • SI Ternopil Regional Dermatovenerologic Dispensary, Ternopil

    Ternopil, 46006

  • MCIC MC LLC Health Clinic, Vinnytsia

    Vinnytsia, 21029

Other trials in Ukraine

Germany5 sites

  • Rothhaar Studien GmbH

    Berlin, 10783

  • Rosenparkklinik GmbH, Darmstadt

    Darmstadt, 64283

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Gemeinschaftspraxis Dr. Bräu Dr. Gross, Gießen

    Giessen, 35390

  • TFS Trial Form Support GmbH

    Hamburg, 20354

Other trials in Germany

Estonia2 sites

  • Center for Clinical and Basic Research, Tallinn

    Tallinn, 10128

  • Hospital of South-Estonia Ltd, Võru Maakond

    Võru Maakond, 65526

Other trials in Estonia

Slovakia2 sites

  • Faculty hospital with clinics F.D. Roosevelta

    Banská Bystrica, 97409

  • Dermatovenerologicke oddelenie sanatorneho typu, Svidnik

    Svidník, 089 01

Other trials in Slovakia

About this study

Official title: Efficacy, Safety, and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial

To evaluate the efficacy and to compare efficacy and safety of BI 695501 versus Humira in patients with moderate to severe chronic plaque psoriasis.

Conditions
Psoriasis
Being tested
BI 695501, Humira
Medical subject headings
Psoriasis

What participants receive

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

  • BI 695501Drug

  • HumiraDrug

Study groups in NCT02850965
Study groupRoleWhat they receive
BI 695501ExperimentalNot described
Receives: Drug: BI 695501
HumiraActive comparatorNot described
Receives: Drug: Humira

What is being measured

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

  1. The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16

    The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 = <10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5 = 70 to <90%, and 6 = 90 to 100% involvement.

    PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.

    Percentage = least squares means per treatment groups back transformed using inverse logit function.

    Measured: Week 16

Secondary outcomes (5)

  1. The Percentage of Patients With a PASI 75 Response at Week 24

    The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 = <10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5 = 70 to <90%, and 6 = 90 to 100% involvement.

    PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.

    Percentage = least squares means per treatment groups back transformed using inverse logit function.

    Measured: Week 24

  2. The Mean Percentage Improvement in PASI at Week 16

    The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 =<10%, 2 =10 to <30%, 3 =30 to <50%, 4 =50 to <70%, 5 =70 to <90%, and 6 =90 to 100% involvement.

    PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.

    Results based on PASI mean percentage improvement from Baseline after 16 weeks of treatment = overall mean + treatment group + Baseline PASI + prior exposure to a biological agent + random error.

    Measured: Week 16

  3. The Percentage of Patients With a Static Physician's Global Assessment (sPGA) ≤1 (Clear or Almost Clear) at Week 16

    The Static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

    The assessment was considered "static", which referred to the patient's disease state at the time of the assessment, without comparison to any of the patient's previous disease states (dynamic), whether at Baseline or at a previous visit. A lower score indicated less body coverage, with 0 being clear, 1 being almost clear, and 4 being.

    Percentage = least squares means per treatment groups back transformed using inverse logit function.

    Measured: Week 16

  4. The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16

    The DLQI is a subject-administered, 10-question, that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has a 1-week recall period. Every item score ranges from 0 (not relevant/not at all) to 3 (very much). Question 7 is a "yes/no" question where "yes" is scored as 3.

    The DLQI total score was calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on the subject's life.

    The higher the score, the more the quality of life is impaired. If the answer to 1 question in a domain was missing, that domain was treated as missing. If 2 or more questions were left unanswered (missing), DLQI total score was treated as missing. Percentage = least squares means per treatment groups back transformed using inverse logit function.

    Measured: Week 16

  5. The Percentage of Patients With Drug-related Adverse Events (AEs)

    The secondary safety endpoint was defined as the percentage of patients with drug-related adverse events (AEs).

    Measured: From first drug administration until 10 weeks after last drug administration, up to 34 weeks.

Timeline

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

  1. First posted1 Aug 2016 (estimated)
  2. Study start17 Aug 2016
  3. Primary completion17 Jan 2018
  4. Study completion17 Jan 2018

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
Double blind
Who is masked
Participant, Investigator
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02850965
Sponsor's protocol ID
1297.12
Other IDs
2016-000613-79, 2016
Status last verified
Jan 2019
First submitted
28 Jul 2016
Last updated
8 Feb 2019

Publications

  • Strand V. Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials. Rheumatol Ther. 2025 Aug;12(4):613-616. doi: 10.1007/s40744-025-00766-6. Epub 2025 Jun 11.

    PubMed 40498294

  • Strand V, McCabe D, Bender S. Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials. BMJ Open. 2024 Nov 17;14(11):e081687. doi: 10.1136/bmjopen-2023-081687.

    PubMed 39551590

  • Menter A, Arenberger P, Balser S, Beissert S, Cauthen A, Czeloth N, Soung J, Jazayeri S, Weisenseel P, Jayadeva G. Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. Expert Opin Biol Ther. 2021 Jan;21(1):87-96. doi: 10.1080/14712598.2021.1851362. Epub 2020 Dec 29.

    PubMed 33317345

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 695501 and Humira in people with Psoriasis, run by Boehringer Ingelheim at 54 sites in 8 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 24 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Poland, Russia, Czechia, Ukraine and 3 more countries. 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 8 Feb 2019). 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?

The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 (time frame: Week 16). 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 NCT02850965, 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 8 Feb 2019.

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