Trials Sponsors Conditions Drugs Pricing

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 695501Drug

BI 695501

HumiraDrug

Humira

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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):

Sponsors & Collaborators

Boehringer Ingelheim
Industrylead

Study Sites (54)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Alliance Dermatology and MOHS Center PC

Phoenix, Arizona, 85032, United States

Southern California Dermatology Inc.

Santa Ana, California, 92701, United States

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

New Horizon Research Center

Miami, Florida, 33175, United States

Renstar Medical Research

Ocala, Florida, 34471, United States

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: 40498294DERIVED
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: 39551590DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

BI 695501Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood Proteins

Results Point of Contact

Title: Boehringer Ingelheim, Call Centre
Organization: Boehringer Ingelheim

Study Officials

Boehringer Ingelheim
Boehringer Ingelheim
STUDY CHAIR

Publication Agreements

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

Enrollment

318 participants (actual enrollment reported by the registry).

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

Actual (reported)

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).
+9 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

BI 695501

Humira

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

BI 695501

Humira

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (54)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations