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

NCT ID: NCT02529956

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-01-31

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.

Conditions

Mild to Moderate Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UCB4940 8 mg

Single intravenous (iv) infusion of UCB4940 8 mg over at least 60 minutes.

Group Type: EXPERIMENTAL

UCB4940

Intervention Type: DRUG

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

UCB4940 40 mg

Single intravenous (iv) infusion of UCB4940 40 mg over at least 60 minutes.

Group Type: EXPERIMENTAL

UCB4940

Intervention Type: DRUG

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

UCB4940 160 mg

Single intravenous (iv) infusion of UCB4940 160 mg over at least 60 minutes.

Group Type: EXPERIMENTAL

UCB4940

Intervention Type: DRUG

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

UCB4940 480 mg

Single intravenous (iv) infusion of UCB4940 480 mg over at least 60 minutes.

Group Type: EXPERIMENTAL

UCB4940

Intervention Type: DRUG

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

UCB4940 640 mg

Single intravenous (iv) infusion of UCB4940 640 mg over at least 60 minutes.

Group Type: EXPERIMENTAL

UCB4940

Intervention Type: DRUG

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

Placebo

Single intravenous (iv) infusion of Placebo over at least 60 minutes.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

UCB4940

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Celltech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 8229493 (UCB)

Locations

1

Harrow, , United Kingdom

Countries

United Kingdom

References

Glatt S, Helmer E, Haier B, Strimenopoulou F, Price G, Vajjah P, Harari OA, Lambert J, Shaw S. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017 May;83(5):991-1001. doi: 10.1111/bcp.13185. Epub 2017 Jan 10.

Reference Type: DERIVED

PMID: 27859546 (View on PubMed)

Other Identifiers

2012-002086-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0008

Identifier Type: -

Identifier Source: org_study_id