A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of UCB4940 in Patients With Psoriasis

Mild to Moderate Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529956
• Other study ID #: UP0008
• Secondary ID: 2012-002086-35
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2015
• Last updated: August 19, 2015
• Start date: November 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mild to Moderate Psoriasis
• Psoriasis

Intervention

Drug:
• UCB4940
Active Substance: UCB4940 Pharmaceutical Form: Solution for infusion Concentration: 80 mg/ml Route of Administration: Intravenous use

Other:
• Placebo
Active Substance: Placebo Pharmaceutical Form: Solution for infusion Concentration: 0.9 % sodium chloride aqueous solution Route of Administration: Intravenous use

Locations

Country	Name	City	State
United Kingdom	1	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
UCB Celltech

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)		Baseline to 20 Weeks	No
Primary	Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)		Baseline to 20 Weeks	No
Primary	Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)		Baseline to 20 Weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	First order terminal elimination rate constant (?z)		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	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)		Baseline to Week 12	No
Secondary	Percentage Change from Baseline to Week 12 in thickness of the plaque		Baseline to Week 12	No
Secondary	Percentage Change from Baseline to Week 12 in lesion area		Baseline to Week 12	No
Secondary	Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)		Baseline to Week 12	No
Secondary	Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)		Baseline to Week 12	No