a study to assess the safety, pharmacokinetics and pharmacodynamics of ucb4940 in patients with psoriasis

Conditions: Mild to Moderate Psoriasis

Summary: to evaluate the safety of ucb4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.


Eligibility criteria:
inclusion criteria: * 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 or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method 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. 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) * subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 5 % of body surface area (bsa) (excluding the scalp) * subject has a body mass index of ≤ 35 kg/m\^2 at screening * subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy exclusion criteria: * 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 * 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 * subject has received treatment with biologic agents within 12 months prior to the study * 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 * subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to imp administration * subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. paracetamol will be permitted for use as an antipyretic and/or analgesic * subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to imp administration. when in doubt, the investigator should confer with the ucb study physician * subject has a history of a positive tuberculosis (tb) test or evidence of possible tb or latent tb infection at screening that cannot be attributed to a prior bacillus calmette-guérin inoculation * subject has renal or liver impairment, defined as: * for women, serum creatinine level ≥ 125 μmol/l; for men, ≥ 135 μmol/l, or * alt and aspartate aminotransferase ≥ 2x uln, or * alkaline phosphatase and bilirubin \> 1.5x uln (an isolated bilirubin \> 1.5x uln is acceptable if bilirubin is fractionated and direct bilirubin is \< 35 %) * subject has active neoplastic disease or history of neoplastic disease within 5 years of screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)

Keywords: psoriasis ucb4940