Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02850965 |
Date of registration:
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28/07/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
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Scientific title:
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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 |
Date of first enrolment:
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August 17, 2016 |
Target sample size:
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318 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02850965 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Czech Republic
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Czechia
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Estonia
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Germany
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Poland
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Russian Federation
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Slovakia
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Ukraine
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- 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.
Exclusion criteria:
- 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).
- 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: Humira
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Drug: BI 695501
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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The Percentage of Patients With a PASI 75 Response at Week 24
[Time Frame: Week 24]
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The Percentage of Patients With Drug-related Adverse Events (AEs)
[Time Frame: From first drug administration until 10 weeks after last drug administration, up to 34 weeks.]
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The Mean Percentage Improvement in PASI at Week 16
[Time Frame: Week 16]
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The Percentage of Patients With a Static Physician's Global Assessment (sPGA) =1 (Clear or Almost Clear) at Week 16
[Time Frame: Week 16]
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The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16
[Time Frame: Week 16]
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Secondary ID(s)
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2016-000613-79
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1297.12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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