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

NCT01032915 | Terminated Phase 3 Results DMC

• 2 other identifiers: CAIN457C23012009-014835-19
• Study Type: interventional
• Target: 125
• Locations: 10 countries
• Sites: 94

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

Non-infectious Uveitis

Keywords

Quiescent uveitis; intermediate uveitis; panuveitis; posterior uveitis; uveitis

Outcome Measures

Primary Outcomes (1)

• Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline

  Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baselineRecurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters

  Baseline to 24 weeks

Secondary Outcomes (3)

• Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks

  Baseline to 24 weeks

• Mean Change in Best Corrected Visual Acuity From Baseline

  Baseline to 24 weeks

• Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks

  Baseline to 24 weeks

Study Arms (4)

AIN457 300mg s.c weekly for 3 weeks

EXPERIMENTAL

AIN457 300mg s.c weekly for 3 weeks then every 2 weeks

Biological: AIN457

AIN457 300mg s.c at baseline and Week 2

EXPERIMENTAL

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

Biological: AIN457

AIN457 150mg s.c at baseline and Week 2

EXPERIMENTAL

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

Biological: AIN457

Placebo s.c weekly for 3 weeks

PLACEBO COMPARATOR

Placebo s.c weekly for 3 weeks then every 2 weeks

Drug: Placebo

Interventions

AIN457 BIOLOGICAL

AIN457 300mg s.c weekly for 3 weeks then every 2 weeks

AIN457 300mg s.c weekly for 3 weeks

Placebo DRUG

Placebo s.c weekly for 3 weeks then every 2 weeks

Placebo s.c weekly for 3 weeks

Eligibility Criteria

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

You may qualify if:

• Patients with quiescent chronic, non-infectious intermediate uveitis, posterior uveitis or panuveitis as evidenced by \<1+ anterior chamber cell grade and \<1+ vitreous haze in both eyes for at least 6 weeks prior to screening.
• Requirement for either of the following immunosuppressive therapies at any time within the past 3 months for the treatment or prevention of uveitis which must not have been increased within the 6 weeks prior to screening:
• Prednisone or equivalent ≥10 mg daily.
• ≥1 periocular injection or ≥1 intravitreal corticosteroid injection (i.e. 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 as monotherapy or in combination with or without steroids. (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.

You may not qualify if:

• Ocular concomitant conditions/disease
• 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 active, non-infectious intermediate, posterior or panuveitis in one or both eyes (≥1+ anterior chamber cells and /or ≥1+ vitreous haze.)
• Patients receiving or that may require corticosteroids (prednisone or equivalent) ≥1 mg/kg/day to maintain quiescence of their intraocular inflammation.
• Ocular treatments
• Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening.
• Treatment with fluocinolone acetonide implant (Retisert®) 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.
• Systemic conditions or treatments
• 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 (94)

Sall Research Medical Center

Artesia, California, 90701, United States

Location

Novartis Investigative Site

Artesia, California, 90704, United States

Location

Novartis Investigative Site

Beverly Hills, California, 90211, United States

Location

Retina-Vitreous Assoc. Medical Group

Beverly Hills, California, 90211, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30322, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40202, United States

Location

University of Louisville Opthamology

Louisville, Kentucky, 40202, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21205-2005, United States

Location

The Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Massachusets Eye Research and Surgery Institution (MERSI)

Cambridge, Massachusetts, 02142, United States

Location

Novartis Investigative Site

Cambridge, Massachusetts, 02142, United States

Location

Novartis Investigative Site

Teaneck, New Jersey, 07666, United States

Location

The Cornea and Laser Institute and UMDNJ

Teaneck, New Jersey, 07666, United States

Location

Charlotte Eye, Ear, Nose, and Throat Associates

Belmont, North Carolina, 28012, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28210, United States

Location

Novartis Investigative Site

Portland, Oregon, 97239, United States

Location

OHSU, Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Novartis Investigative Site

Arlington, Texas, 76012, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Novartis Investigative Site

Houston, Texas, 77025, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Novartis Investigative Site

Seattle, Washington, 98195, United States

Location

Novartis Investigative Site

São Paulo, São Paulo, 04023-900, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 05403-000, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, 21941-590, Brazil

Location

Novartis Investigative Site

São Paulo, 04040-002, Brazil

Location

Novartis Investigative Site

São Paulo, 05403-000, Brazil

Location

Novartis Investigative Site

Berlin, 13353, Germany

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Novartis Investigative Site

Chemnitz, 09113, Germany

Location

Novartis Investigative Site

Dessau, 06847, Germany

Location

Novartis Investigative Site

Dessau, D-06822, Germany

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Novartis Investigative Site

Essen, 45122, Germany

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Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Münster, 48145, Germany

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Novartis Investigative Site

Tübingen, 72076, Germany

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Novartis Investigative Site

Bangalore, Karnataka, 560 010, India

Location

Novartis Investigative Site

Chennai, Tamil Nadu, 600006, India

Location

Novartis Investigative Site

Madurai, Tamil Nadu, 625020, India

Location

Novartis Investigative Site

Hyderabad, Telangana, 500 034, India

Location

Novartis Investigative Site

Chandigarh, 160 012, India

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Novartis Investigative Site

Chennai, 600006, India

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Novartis Investigative SIte

Coimbatore, 641014, India

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Novartis Investigative Site

Kolkata, 700 073, India

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Novartis Investigative Site

Madurai, 625020, India

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Novartis Investigative Site

New Delhi, 110 029, India

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Novartis Investigative Site

Jerusalem, 91120, Israel

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Novartis Investigative Site

Petah Tikva, 49100, Israel

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Novartis Investigative Site

Ramat Gan, 5262100, Israel

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Novartis Investigative Site

Tel Aviv, 64239, Israel

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Parma, PR, 43100, Italy

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Novartis Investigative Site

Roma, RM, 00100, Italy

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Novartis Investigative Site

Ancona, 60126, Italy

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Novartis Investigative Site

Milan, 20132, Italy

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Novartis Investigative Site

Milan, 20157, Italy

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Novartis Investigative Site

Parma, 43100, Italy

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Novartis Investigative Site

Roma, 00100, Italy

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Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

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Novartis Investigative Site

Santiago de Compostela, Galicia, 15705, Spain

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Novartis Investigative Site

Madrid, Madrid, 28040, Spain

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Novartis Investigative Site

Valencia, Valencia, 46026, Spain

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Novartis Investigative Site

Barakaldo, Vizcaya, 48903, Spain

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Novartis Investigative Site

Barakaldo, 48903, Spain

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Novartis Investigative Site

Barcelona, 08028, Spain

Location

Novartis Investigative Site

Barcelona, 08035, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Santiago de Compostela, 15705, Spain

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Novartis Investigative Site

Valencia, 46009, Spain

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Novartis Investigative Site

Valencia, 46014, Spain

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Novartis Investigative Site

Lausanne, CHE, 1004, Switzerland

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Novartis Investigative Site

Lausanne, Switzerland, 1003, Switzerland

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Novartis Investigative Site

Zurich, Switzerland, 8063, Switzerland

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Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Bern, 3012, Switzerland

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Novartis Investigative Site

Lausanne, 1003, Switzerland

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Novartis Investigative Site

Lausanne, 1004, Switzerland

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Novartis Investigative Site

Lucerne, 6000, Switzerland

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Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

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Novartis Investigative Site

Zurich, 8063, Switzerland

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Novartis Investigative Site

Ankara, 06490, Turkey (Türkiye)

Location

Novartis Investigative Site

Fatih / Istanbul, 34098, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34390, Turkey (Türkiye)

Location

Novartis Investigative Site

Birmingham, B18 7QU, United Kingdom

Location

Novartis Investigative Site

Bristol, BD1 2LX, United Kingdom

Location

Novartis Investigative Site

Bristol, BS1 2LX, United Kingdom

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Novartis Investigative Site

Liverpool, L7 8XP, United Kingdom

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Novartis Investigative Site

London, EC1V 2PD, United Kingdom

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Novartis Investigative Site

London, SE1 7EH, United Kingdom

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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, Intermediate; Panuveitis; Uveitis, Posterior; Uveitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis

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: December 14, 2009
• First Posted: December 16, 2009
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 5, 2015
• Results First Posted: November 5, 2015

Record last verified: 2015-10

Locations

US (24); IT (8); CH (10); ES (13); GB (7); IL (4); DE (10); IN (10); TU (3); BR (5)