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

NCT02529956 | Completed Phase 1

• 2 other identifiers: UP00082012-002086-35
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

Psoriasis; UCB4940

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• 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

Study Arms (6)

UCB4940 8 mg

EXPERIMENTAL

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

Drug: UCB4940

UCB4940 40 mg

EXPERIMENTAL

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

Drug: UCB4940

UCB4940 160 mg

EXPERIMENTAL

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

Drug: UCB4940

UCB4940 480 mg

EXPERIMENTAL

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

Drug: UCB4940

UCB4940 640 mg

EXPERIMENTAL

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

Drug: UCB4940

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

UCB4940 DRUG

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

UCB4940 160 mg; UCB4940 40 mg; UCB4940 480 mg; UCB4940 640 mg; UCB4940 8 mg

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UCB Celltech: lead

Study Sites (1)

1

Harrow, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27859546 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• UCB Clinical Trial Call Center

  +1 877 8229493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

GB (1)