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

NCT01250171 | Completed Phase 2 Results

• 1 other identifier: CPJMR0092202
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Dry eye; IL17/ IL-1β; Biologic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4

  Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.

  Baseline to Week 4

Secondary Outcomes (7)

• Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8

  Baseline to Weeks 1, 4, and 8

• Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8

  Baseline to Weeks 1, 4, and 8

• Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8

  Baseline to Weeks 1, 4, and 8

• Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8

  Baseline to Weeks 1, 4, and 8

• Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8

  Baseline to Weeks 1, 4, and 8

Study Arms (3)

Secukinumab 10 mg/kg

EXPERIMENTAL

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

Biological: Secukinumab 10 mg/kg

Canakinumab 10 mg/kg

EXPERIMENTAL

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

Biological: Canakinumab 10 mg/kg

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Secukinumab 10 mg/kg BIOLOGICAL

Secukinumab was prepared in a sterile water solution.

Also known as: AIN457

Secukinumab 10 mg/kg

Canakinumab 10 mg/kg BIOLOGICAL

Canakinumab was prepared in a sterile water solution.

Also known as: ACZ885

Canakinumab 10 mg/kg

Placebo BIOLOGICAL

The placebo solution for infusion contained 5% glucose.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Ora Inc, 300 Brickstone Square,

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

secukinumab; canakinumab

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 7, 2013
• Results First Posted: January 7, 2013

Record last verified: 2012-12

Locations

US (1)