Mild to Moderate Psoriasis
Conditions
Keywords
Psoriasis, UCB4940
Brief summary
To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.
Interventions
DRUGUCB4940
* Active Substance: UCB4940 * Pharmaceutical Form: Solution for infusion * Concentration: 80 mg/ml * Route of Administration: Intravenous use
OTHERPlacebo
* Active Substance: Placebo * Pharmaceutical Form: Solution for infusion * Concentration: 0.9 % sodium chloride aqueous solution * Route of Administration: Intravenous use
Sponsors
UCB Celltech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) | Baseline to 20 Weeks |
| Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) | Baseline to 20 Weeks |
| Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) | Baseline to 20 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax (Tmax) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Terminal elimination half-life (t1/2) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| First order terminal elimination rate constant (λz) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Total body clearance (CL) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Volume of distribution in terminal phase (Vz) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Maximum plasma concentration (Cmax) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Percentage Change from Baseline to Week 12 in thickness of the plaque | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in lesion area | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA) | Baseline to Week 12 |
| Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS) | Baseline to Week 12 |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf)) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
| Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t)) | Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20 |
Countries
United Kingdom
Outcome results
None listed