The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients

NCT ID: NCT01250171

Last Updated: 2013-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-09-30

Brief Summary

This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. Blood samples were collected for the analysis of the effect of secukinumab and canakinumab on select biomarkers.

Conditions

Dry Eye

Study Design

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

Study Groups

Secukinumab 10 mg/kg

Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.

Group Type: EXPERIMENTAL

Secukinumab 10 mg/kg

Intervention Type: BIOLOGICAL

Secukinumab was prepared in a sterile water solution.

Canakinumab 10 mg/kg

Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.

Group Type: EXPERIMENTAL

Canakinumab 10 mg/kg

Intervention Type: BIOLOGICAL

Canakinumab was prepared in a sterile water solution.

Placebo

Patients received a single placebo infusion intravenously over a 2 hour period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

The placebo solution for infusion contained 5% glucose.

Interventions

Secukinumab 10 mg/kg

Secukinumab was prepared in a sterile water solution.

Intervention Type: BIOLOGICAL

Canakinumab 10 mg/kg

Canakinumab was prepared in a sterile water solution.

Intervention Type: BIOLOGICAL

Placebo

The placebo solution for infusion contained 5% glucose.

Intervention Type: BIOLOGICAL

Other Intervention Names

AIN457; ACZ885

Eligibility Criteria

Inclusion Criteria

• Male and female patients age 18-85 with a diagnosis of moderate to severe dry eye.
• Schirmer test without anesthesia ≥ 1 and < 10 mm wetting over 5 minutes in at least 1 eye.
• Tear break up time < 7 seconds in at least 1 eye.
• Corneal staining score ≥ 3 (National Eye Institute [NEI] grading scale).
• Conjunctival redness of ≥ 1.
• Ocular surface disease index of modest to severe.
• Ability to provide informed consent.

Exclusion Criteria

• Pregnant or breastfeeding women.
• Hemoglobin < 10 g/dl.
• Total white blood count (WBC) outside the range of 3000-14,000/µl.
• Platelets < 100,000/µl.
• Use of ocular, periocular, or systemic steroids within 60 days prior to screening.
• Use of contact lenses or prior corneal refractive surgery in either eye.
• Requirement of eye drop use during the study.
• Anesthetic or neurotrophic corneas.
• Temporary punctal plugs.
• Recent or planned exposure to live vaccinations.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Ora Inc, 300 Brickstone Square,

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

CPJMR0092202

Identifier Type: -

Identifier Source: org_study_id