Phase III Study in Refractory Behcet's Disease

NCT00995709 | Completed Phase 3 Results

• 2 other identifiers: CAIN457C23032009-011237-27
• Study Type: interventional
• Target: 118
• Locations: 16 countries
• Sites: 43

Brief Summary

The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.

Conditions

Behcet Disease

Keywords

Behçet's disease,; intermediate uveitis; panuveitis; posterior uveitis; uveitis

Outcome Measures

Primary Outcomes (2)

• Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment

  Baseline to week 24

• Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment

  Patients number of occurences during a 24 week period.

  24 weeks

Secondary Outcomes (4)

• Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)

  24 weeks

• To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet's Disease as Determined by Optical Coherence Tomography.

  baseline, and wk 24 (end of study)

• To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet's Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.

  screening, and wk 24 (end of study)

• To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet's Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet's Disease Current Activity Form.

  baseline and wk 24 (end of study)

Study Arms (3)

AIN457C 300 mg every 2 week dosage regimen

EXPERIMENTAL

AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each. every 2 weeks

Drug: AIN457

AIN457C 300 mg monthly dosage regimen

EXPERIMENTAL

AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg e

Drug: AIN457

Placebo

PLACEBO COMPARATOR

Placebo was administered in 2 s.c. injections every 2 weeks

Drug: Placebo

Interventions

AIN457 DRUG

AIN457C 300 mg every 2 week dosage regimen

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients with Behçet's disease and with a history of recurrent uveitis in a least one eye.
• \>2+ vitreous haze with \<2+ anterior chamber cell grade (intermediate or posterior uveitis) or \>2+ vitreous haze with \>2+ anterior chamber cell grade (panuveitis)
• presence of retinal infiltrates or vasculitis or hemorrhages
• documented \>10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçet's disease.
• Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçet's disease:
• Prednisone or equivalent \>10 mg daily
• The need for at least \>1 periocular injection or \>1 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have not been given within 6 weeks of screening)
• Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids. (Patients treated at any time with chlorambucil or cyclophosphamide are not eligible for the study.)
• Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator.

You may not qualify if:

• Subjects with infectious uveitis, uveitis due to other causes than Behçet's disease, or uveitis of unknown etiology.
• Less severe (i.e. anterior) uveitis associated with Behçet's disease.
• Ocular treatments
• Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening.
• Treatment with any injected or implantable corticosteroid releasing device (i.e., flucinolone acetonide implant, Retisert®) in the study eye within the last 3 years.
• 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
• Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening.
• Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457.
• Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (49)

Novartis Investigative Site

Baltimore, Maryland, 21205-2005, United States

Location

Novartis Investigative Site

Arlington, Texas, 76012, United States

Location

Novartis Investigative Site

Houston, Texas, 77025, United States

Location

Novartis Investigative Site

Alexandria, Egypt

Location

Novartis Investigative Site

Grenoble, 38043, France

Location

Novartis Investigative Site

Dessau, 06847, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Athens, Greece, GR 156 69, Greece

Location

Novartis Investigative Site

Larissa, Greece, GR 41110, Greece

Location

Novartis Investigative Site

Athens, GR, 115 27, Greece

Location

Novartis Investigative Site

Heraklion - Crete, GR, 711 10, Greece

Location

Novartis Investigative Site

Ioannina, GR, 455 00, Greece

Location

Novartis Investigative Site

Larissa, GR, 41110, Greece

Location

Novartis Investigative Site

Ioannina, 45500, Greece

Location

Novartis Investigative Site

Pátrai, 26500, Greece

Location

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Chennai, Tamil Nadu, 600006, India

Location

Novartis Investigative Site

Madurai, Tamil Nadu, 625020, India

Location

Novartis Investigative Site

Angamaly, 683572, India

Location

Novartis Investigative Site

New Delhi, 110 029, India

Location

Novartis Investigative Site

Afula, 18101, Israel

Location

Novartis Investigative Site

Nahariya, 22100, Israel

Location

Novartis Investigative Site

Ramat Gan, 52621, Israel

Location

Novartis Investigative Site

Tel Aviv, 64239, Israel

Location

Novartis Investigative Site

Ancona, AN, 60126, Italy

Location

Novartis Investigative Site

Milan, MI, 20132, Italy

Location

Novartis Investigative Site

Amman, 11195, Jordan

Location

Novartis Investigative Site

Irbid, 22110, Jordan

Location

Novartis Investigative Site

Singapore, Singapore, 308433, Singapore

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 120-752, South Korea

Location

Novartis Investigative Site

Barcelona, Barcelona, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08028, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Spain

Location

Novartis Investigative Site

Lausanne, Switzerland, 1003, Switzerland

Location

Novartis Investigative Site

Bern, 3012, Switzerland

Location

Novartis Investigative Site

Lin-Ko, 33305, Taiwan

Location

Novartis Investigative Site

Monastir, 5019, Tunisia

Location

Novartis Investigative Site

Sfax, Tunisia

Location

Novartis Investigative Site

Tunis, Tunisia

Location

Novartis Investigative Site

Ankara, Turkey, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey, 06490, Turkey (Türkiye)

Location

Novartis Investigative Site

Altindag / Ankara, 06590, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34093, Turkey (Türkiye)

Location

Novartis Investigative Site

Istanbul, 34303, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35380, Turkey (Türkiye)

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

Behcet Syndrome; Uveitis, Intermediate; Panuveitis; Uveitis, Posterior; Uveitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

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: October 13, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 31, 2015
• Results First Posted: August 31, 2015

Record last verified: 2015-08

Locations

TU (3); KR (2); CH (2); TW (1); DE (4); EG (1); GR (8); FR (1); HK (1); IT (2); US (3); IL (4); IN (4); JO (2); SG (1); ES (4)