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

Phase 1

Completed

• Conditions: Mild to Moderate Psoriasis
• Interventions: Drug: UCB4940; Other: Placebo

• Registration Number: NCT02529956
• Lead Sponsor: UCB Celltech

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-08
• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-08-19
• Last Update Submitted: 2015-08-19
• Study First Posted: 2015-08-20
• Last Update Posted: 2015-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCB4940 8 mg	UCB4940	Single intravenous (iv) infusion of UCB4940 8 mg over at least 60 minutes.
UCB4940 40 mg	UCB4940	Single intravenous (iv) infusion of UCB4940 40 mg over at least 60 minutes.
UCB4940 160 mg	UCB4940	Single intravenous (iv) infusion of UCB4940 160 mg over at least 60 minutes.
UCB4940 480 mg	UCB4940	Single intravenous (iv) infusion of UCB4940 480 mg over at least 60 minutes.
UCB4940 640 mg	UCB4940	Single intravenous (iv) infusion of UCB4940 640 mg over at least 60 minutes.
Placebo	Placebo	Single intravenous (iv) infusion of Placebo over at least 60 minutes.

Primary Outcome Measures

Name	Time	Method
Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)	Baseline to 20 Weeks
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)	Baseline to Week 12
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

Trial Locations

Locations (1)

1; 🇬🇧 Harrow, United Kingdom