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

NCT02850965 | Completed Phase 3 Results

• 2 other identifiers: 1297.122016-000613-79
• Study Type: interventional
• Target: 318
• Locations: 8 countries
• Sites: 54

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (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.

  Week 16

Secondary Outcomes (5)

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

  Week 24

• The Mean Percentage Improvement in PASI at Week 16

  Week 16

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

  Week 16

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

  Week 16

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

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

Study Arms (2)

BI 695501

EXPERIMENTAL

Drug: BI 695501

Humira

ACTIVE COMPARATOR

Drug: Humira

Interventions

BI 695501 DRUG

BI 695501

Humira DRUG

Humira

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (54)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Alliance Dermatology and MOHS Center PC

Phoenix, Arizona, 85032, United States

Location

Southern California Dermatology Inc.

Santa Ana, California, 92701, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Advanced Clinical Research

Boise, Idaho, 83642, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Altoona Center for Clinical Research, P.C.

Duncansville, Pennsylvania, 16635, United States

Location

Medical Research South

Charleston, South Carolina, 29407, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Dorothea

Chomutov, 43004, Czechia

Location

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

Olomouc-Povel, 779 00, Czechia

Location

University Hospital Ostrava

Ostrava, 708 52, Czechia

Location

HOMEA spol. s.r.o., Pardubice

Pardubice, 530 02, Czechia

Location

Univ. Hospital Kralovske Vinohrady

Prague, 100 34, Czechia

Location

MU Dr. Jaroslav Dragon, Ústí nad Labem

Ústí nad Labem, 400 10, Czechia

Location

Center for Clinical and Basic Research, Tallinn

Tallinn, 10128, Estonia

Location

Hospital of South-Estonia Ltd, Võru Maakond

Võru Maakond, 65526, Estonia

Location

Rothhaar Studien GmbH

Berlin, 10783, Germany

Location

Rosenparkklinik GmbH, Darmstadt

Darmstadt, 64283, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Gemeinschaftspraxis Dr. Bräu Dr. Gross, Gießen

Giessen, 35390, Germany

Location

TFS Trial Form Support GmbH

Hamburg, 20354, Germany

Location

NZOZ Specderm, Bialystok

Bialystok, 15-017, Poland

Location

ClinicMed Badurski i wspolnicy Spolka Jawna, Bialystok

Bialystok, 15-879, Poland

Location

NSZOZ Unica CR, Dabrowka

Dąbrówka, 62-069, Poland

Location

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

Gdansk, 80-382, Poland

Location

University Clinical Center, Gdansk

Gdansk, 80-952, Poland

Location

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

Gdynia, 81-384, Poland

Location

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

Katowice, 40-040, Poland

Location

SOLUMED Centrum Medyczne, Poznan

Poznan, 60-529, Poland

Location

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

Szczecin, 70-332, Poland

Location

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

Warsaw, 01-192, Poland

Location

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

Wroclaw, 50-088, Poland

Location

State Medical University, Kazan

Kazan', 420012, Russia

Location

LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

Saint Petersburg, 190123, Russia

Location

Dermatovenereological Dispensary #10, St. Petersburg

Saint Petersburg, 194021, Russia

Location

ArsVitae NorthWest LLC

Saint Petersburg, 194223, Russia

Location

EKO-Bezopasnost, St. Petersburg

Saint Petersburg, 196143, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

Institution of Healthcare "Nikolaevskaya Hospital"

Saint Petersburg, 198510, Russia

Location

Smolensk State Medical University, Smolensk

Smolensk, 214019, Russia

Location

Faculty hospital with clinics F.D. Roosevelta

Banská Bystrica, 97409, Slovakia

Location

Dermatovenerologicke oddelenie sanatorneho typu, Svidnik

Svidník, 089 01, Slovakia

Location

Territorial Medical Association Dermatovenerology, Kyiv

Kyiv, 01032, Ukraine

Location

CH of State Border Service of Ukraine, Lviv

Lviv, 79014, Ukraine

Location

CI Odesa Regional Dermatovenerologic Dispensary, Odesa

Odesa, 65006, Ukraine

Location

CI RC Dermatovenerologic Dispensary, Ivano-Frankivsk

Saint Ivano-Frankivsk, 76018, Ukraine

Location

SI Ternopil Regional Dermatovenerologic Dispensary, Ternopil

Ternopil, 46006, Ukraine

Location

MCIC MC LLC Health Clinic, Vinnytsia

Vinnytsia, 21029, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 40498294 DERIVED

• 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.

  PMID: 39551590 DERIVED

• 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.

  PMID: 33317345 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

BI 695501; Adalimumab

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: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: August 17, 2016
• Primary Completion: January 17, 2018
• Study Completion: January 17, 2018
• Last Updated: February 8, 2019
• Results First Posted: February 8, 2019

Record last verified: 2019-01

Locations

ES (2); SL (2); RU (8); UA (6); PL (11); US (14); CZ (6); DE (5)