A randomized, subject-blind, investigator-blind, placebo-controlled, single-dose, dose escalating study evaluating the safety, pharmacokinetics, and pharmacodynamics of UCB4940 in patients with mild to moderate psoriasis

CB Celltech0 sites39 target enrollmentSeptember 21, 2012

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: CB Celltech
Enrollment: 39
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 21, 2012

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

CB Celltech

Eligibility Criteria

Inclusion Criteria

•1\. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject prior to the initiation of any study\-specific assessment at Screening.
•2\. Subject is considered reliable and capable of adhering to the protocol, according to the judgment of the Investigator, and has adequate reading and writing abilities (in his/her native
•language) such that the subject can comprehend and answer the questions on the subject\-completed assessments.
•3\. Subject is male or female, aged \=18 years to \=70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method (eg, male condom,
•female condom, or diaphragm with spermicide) during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives,
•progesterone\-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner (where post vasectomy testing has demonstrated
•sperm clearance). Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half\-lives).
•4\. Subject has had a confirmed diagnosis of mild to moderate plaque\-type psoriasis for at least 6 months involving \=5% of BSA (excluding the scalp).
•5\. Subject has a body mass index of \=35kg/m2 at Screening.
•6\. Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy.

Exclusion Criteria

•1\. Subject has a personal history of polysorbate 80, sorbitol, and/or fructose intolerance.
•2\. Subject has donated more than 400mL of blood or blood products within 90 days prior to check\-in (Day \-2\) or plans to donate blood during the study.
•3\. Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study.
•4\. Subject is an employee or direct relative of an employee of PAREXEL or UCB.
•5\. Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method.
•Exclusion criteria related to drugs:
•6\. Subject has received systemic nonbiologic psoriasis therapy (methotrexate \[MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
•7\. Subject has received treatment with biologic agents within 12 months prior to the study.
•8\. Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study.
•9\. Subject has received any investigational drug or experimental procedure within 90 days or 5 half\-lives, whichever is longer, prior to IMP administration.