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

Phase 1

Conditions: Moderate to Severe Chronic Plaque Psoriasis
MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2016-000613-79-DE

Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. 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 first administration of study drug, and which has been stable for the last 2 months with no changes in morphology or significant flares at both Screening and Baseline (Randomization):
a. involved BSA = 10% and
b. PASI score = 12 and
c. sPGA score of = 3.
2. Participants of reproductive potential (childbearing potential) willing and able to use highly effective methods of birth control.
3. Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial.
4. Patients who are candidates for systemic therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Active inflammatory diseases other than psoriasis that might confound trial evaluations.
2. Previous treatment with more than 1 biological agent, or adalimumab or adalimumab Biosimilar. No prior biologic exposure within last 6 months of screening will be permitted.
3. significant disease other than psoriasis and/or a significant uncontrolled Disease.
4. Major surgery performed within 12 weeks prior to randomization or planned within 6 months after screening.
5. 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.
6. 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.
7. Currently enrolled in another investigational device or drug study.
8. Chronic alcohol or drug abuse.
9. Women who are pregnant, nursing, or who plan to become pregnant during the study or within 6 months following completion or discontinuation from trial.
10. Forms of psoriasis other than chronic plaque psoriasis. Drug-induced psoriasis.
11. Primary or secondary immunodeficiency, including known history of HIV infection or a positive HIV test at screening.
12. Known chronic or relevant acute tuberculosis.
13. Known clinically significant coronary artery disease, significant cardiac arrhythmias, moderate to severe congestive heart failure or interstitial lung disease observed on chest X-ray.
14. History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a previously used biological drug or its excipients.
15. Positive serology for hepatitis B virus (HBV) or hepatitis C virus (HCV).
16. 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.
17. Any treatment that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
18. 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 or completion of oral anti-infectives within 2 weeks of the Screening Visit.
19. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper limit of normal (ULN) at Screening.
20. Hemoglobin < 8.0 g/dL at Screening.
21. Platelets < 100,000/µL at Screening.
22. Leukocyte count < 4000/µL at Screening.
23. Creatinine clearance < 60 mL/min/1.73 m2 at Screening.
24. Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins, or natural rubber and latex, including serious allergic reactions.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate equivalence in efficacy between BI 695501 and US-licensed Humira® at Week 16 in patients with active moderate to severe chronic plaque psoriasis.;Secondary Objective: To compare the safety and efficacy profiles of BI 695501 and US-licensed Humira.<br>;Primary end point(s): Proportion of patients with a 75% reduction in Psoriasis Area and Severity Index (PASI 75);Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy endpoints:<br>• Proportion of patients with a PASI 75 response<br>• Mean percentage improvement in PASI <br>• Proportion of patients with a sPGA = 1 (clear or almost clear)<br>• Proportion of patients achieving a Dermatology Life Quality Index (DLQI) of 0 or 1<br>Safety endpoint:<br>• Proportion of patients with drug-related AEs;Timepoint(s) of evaluation of this end point: Efficacy endpoints:<br>• Proportion of patients with a PASI 75 response at Week 24<br>• Mean percentage improvement in PASI at Week 16<br>• Proportion of patients with a sPGA = 1 (clear or almost clear) at Week 16<br>• Proportion of patients achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16<br>Safety endpoint:<br>• Proportion of patients with drug-related AEs (for the duration of the study)