A Study of the Safety, Tolerability, Pharmacokinetics (What the Body Does to the Drug), and Pharmacodynamics (What the Drug Does to the Body) of CNTO 1959 Following a Single Subcutaneous (Under the Skin) Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis

NCT01484587 | Completed Phase 1 DMC

• 2 other identifiers: CR018646CNTO1959PSO1002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of CNTO 1959 following a single subcutaneous (SC, under the skin) dose administered to Japanese participants with moderate to severe plaque psoriasis.

Conditions

Psoriasis

Keywords

Moderate to Severe Plaque-Type Psoriasis; Psoriasis; Plaque-type psoriasis; CNTO 1959; Japanese participants

Outcome Measures

Primary Outcomes (7)

• The number and type of adverse events

  Up to 24 weeks

• Change in clinical laboratory values

  Up to 24 weeks

• Electrocardiogram

  Up to 24 weeks

• Changes or abnormalities in body systems

  Up to 24 weeks

• Axillary temperature

  Up to 24 weeks

• Pulse rate

  Up to 24 weeks

• Blood pressure

  Up to 24 weeks

Secondary Outcomes (4)

• Blood levels of CNTO 1959

  Up to 24 weeks

• Antibodies to CNTO 1959

  Up to 24 weeks

• Psoriasis Area and Severity Index (PASI)

  Up to 24 weeks

• Physician's Global Assessment (PGA)

  Up to 24 weeks

Study Arms (2)

001

EXPERIMENTAL

Drug: CNTO 1959

002

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CNTO 1959 DRUG

CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks

001

Placebo DRUG

Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks

002

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of plaque-type psoriasis at least 6 months prior to screening (participants with concurrent psoriatic arthritis may be enrolled)
• Having plaque-type psoriasis covering at least 10% of total body surface area (BSA) at baseline
• Has a Psoriasis Area and Severity Index (PASI) score of 12 or greater at baseline
• Is a candidate for systemic phototherapy or systemic treatment of psoriasis (either new to treatment or having had previous treatment)
• Has at least 2 plaques suitable for repeat biopsy (Only participants who consent separately to participate in this assessment. Refusal to give consent for this component does not exclude an individual from participation in the clinical study).

You may not qualify if:

• Currently has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular)
• Has current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g., secondary infection occurred on bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers
• Has a history of latent, or active or opportunistic systemic infection with pathogens including, but not limited to, Klebsiella pneumoniae, Cryptococcus neoformans, Candida albicans, Toxoplasma gondii, and Pneumocystis jiroveci prior to screening
• Has or has had a serious infection (e.g., sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous antibiotics for an infection during the 2 months prior to screening

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Sapporo, Japan

Location

Related Links

• Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 following a Single Subcutaneous Administration in Japanese Subjects With Moderate to Severe Plaque Psoriasis

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: December 2, 2011
• Study Start: August 22, 2011
• Primary Completion: April 11, 2013
• Study Completion: April 11, 2013
• Last Updated: September 5, 2017

Record last verified: 2017-09

Locations

JP (1)