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

Novartis

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Biological: Canakinumab 10 mg/kg; Biological: Placebo; Biological: Secukinumab 10 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250171

CPJMR0092202

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups, including a placebo group

Secukinumab 10 mg/kg

Experimental group

Description:

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

Treatment:

Biological: Secukinumab 10 mg/kg

Canakinumab 10 mg/kg

Experimental group

Description:

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

Treatment:

Biological: Canakinumab 10 mg/kg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo