Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

NCT01095250 | Terminated Phase 3 Results

• 2 other identifiers: CAIN457C23022009-014834-22
• Study Type: interventional
• Target: 30
• Locations: 13 countries
• Sites: 36

Brief Summary

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

Conditions

Uveitis

Keywords

Active uveitis; intermediate uveitis; panuveitis; posterior uveitis; uveitis

Outcome Measures

Primary Outcomes (1)

• Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.

  No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.

  baseline to 28 weeks

Secondary Outcomes (5)

• Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks

  baseline to 28 weeks

• Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks

  baseline to 28 weeks

• Change From Baseline in Quality of Life/Patient Reported Outcome Assessments

  baseline to 28 weeks

• Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks

  baseline to 28 weeks

• Change in Immunosuppressive Medication Score From Baseline to Week 28

  baseline to 28 weeks

Study Arms (4)

AIN457 300mg s.c every 2 weeks

EXPERIMENTAL

AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks.

Drug: AIN457

AIN457 300mg s.c. every 4 weeks

EXPERIMENTAL

AIN457 300 mg s.c. at baseline and Week 2, then every 4 weeks.

Drug: AIN457

AIN457 150mg s.c every 4 weeks

EXPERIMENTAL

AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks

Drug: AIN457

Placebo s.c every 2 weeks

PLACEBO COMPARATOR

Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks

Drug: Placebo

Interventions

AIN457 DRUG

AIN457 300mg s.c every 2 weeks

Placebo DRUG

Placebo s.c every 2 weeks

Eligibility Criteria

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

You may qualify if:

• Male and female subjects ≥18 years of age. Where relevant, parents will also sign the informed consent according to local laws and regulations
• Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye
• Evidence of active intermediate, posterior or panuveitis (grade ≥ 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye
• Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis:
• Prednisone or equivalent ≥10 mg daily at any time within the past 3 months.
• ≥1 periocular injection or ≥1 intravitreal corticosteroid injection (e.g. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening).
• Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate at any time within the past 3 months (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study).
• Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator.
• Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed

You may not qualify if:

• Ocular concomitant conditions/disease
• Patients receiving or that may require prednisone (or equivalent) ≥1.5 mg/kg/day for the treatment of their active uveitis
• Patients with a primary diagnosis of Behcet's disease, anterior uveitis or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (i.e. Punctate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR)
• Patients with infectious uveitis or uveitis of an underlying diagnosis that is uncertain and would reasonably include a disease for which immunosuppression would be contraindicated (e.g. ocular lymphoma)
• Ocular treatments
• Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening
• Treatment with fluocinolone acetonide implant in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months.
• Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle
• Ocular disease that would interfere with ocular evaluations (e.g. corneal scarring, cataract, vitreous hemorrhage) or that in the opinion of the investigator would complicate the evaluation of the safety or efficacy of the study treatment (e.g. uncontrolled glaucoma, toxoplasma scar, macular scarring)
• Current use of or likely need for systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine, ethambutol, etc.)
• Systemic conditions or treatments
• Any previous treatment with AIN457
• Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening. No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial
• Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening
• Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening. No treatment with live or live-attenuated vaccines will be allowed during the course of the clinical trial

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (36)

Novartis Investigative Site

Beverly Hills, California, 90211, United States

Location

Novartis Investigative Site

Cambridge, Massachusetts, 02142, United States

Location

Novartis Investigative Site

Slingerlands, New York, 12159, United States

Location

Novartis Investigative Site

Arlington, Texas, 76012, United States

Location

Novartis Investigative Site

Houston, Texas, 77025, United States

Location

Novartis Investigative Site

London, Ontario, N6A 4G5, Canada

Location

Novartis Investigative Site

North York, Ontario, M3N 2V6, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3A 1A1, Canada

Location

Novartis Investigative Site

Cairo, Egypt

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Göttingen, D-37075, Germany

Location

Novartis Investigative Site

Budapest, 1083, Hungary

Location

Novartis Investigative Site

Ahmedabad, Gujarat, 380004, India

Location

Novartis Investigative Site

Afula, 18101, Israel

Location

Novartis Investigative Site

Petah Tikva, 49100, Israel

Location

Novartis Investigative Site

Ramat Gan, 52621, Israel

Location

Novartis Investigative Site

Tel Aviv, 64239, Israel

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Fukushima, Fukushima, 960-1295, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 602-8566, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565-0871, Japan

Location

Novartis Investigative Site

Shimotsuka-gun, Tochigi, 321-0293, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Novartis Investigative Site

Mitaka, Tokyo, 181-8611, Japan

Location

Novartis Investigative Site

Singapore, Singapore, 308433, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Lausanne, CHE, 1004, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Bern, 3012, Switzerland

Location

Novartis Investigative Site

Lucerne, 6000, Switzerland

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

York, YO31 8HE, United Kingdom

Location

Related Publications (1)

• Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.

  PMID: 23290985 DERIVED

MeSH Terms

Conditions

Uveitis; Uveitis, Intermediate; Panuveitis; Uveitis, Posterior

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Limitations and Caveats

Study CAIN457C2302 was terminated to avoid continuing patients on a study with a low probability of success. Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 30, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 3, 2015
• Results First Posted: November 3, 2015

Record last verified: 2015-10

Locations

GB (1); HU (1); JP (9); EG (1); DE (2); FR (1); IN (1); SG (1); IL (4); ES (2); CH (5); US (5); CA (3)