Clinical trial NCT00685399: Safety and Efficacy of AIN457 in Noninfectious Uveitis
Official title: An Open-label Proof-of-concept Study With a Double-masked, Dose-ranging Component to Assess the Effects of AIN457 in Patients With Noninfectious Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-infectious Uveitis
Keywords: Uveitis
eye
IL-17
IL-17A
IL17
AIN457
Vogt-Koyanagi-Harada
Behcet's
Behcet
Sympathetic ophthalmia
Multifocal choroiditis
Birdshot
HLA-B27
Birdshot retinochoroiditis
Retinal vasculitis
Sarcoidosis
Intermediate uveitis
Panuveitis
Posterior uveitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was performed to evaluate the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.


Eligibility criteria: Inclusion criteria:

* Active uveitis (i.e., uveitis that is not in remission).
* Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated.

Exclusion criteria:

* Active infection.
* Weight must not be greater that 120kg.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died
timeFrame: Day 1 to Day 603
Secondary outcomes:
measure: Number of Responders in Cohort 1, 2, 3 and 6 at Day 57
timeFrame: Day 1 (Baseline), Day 57
measure: Number of Complete Responders in Cohort 2, 3 and 6 at Day 57
timeFrame: Day 1 (Baseline), Day 57
measure: Number of Participants With Reduction in Oral Prednisone or Topical Corticosteroid and Other Immunosuppressant Drugs
timeFrame: Baseline (Day 1) up to Month 8
measure: Number of Participants Who Were Able to Induce a Remission in Uveitis
timeFrame: Day 1 to Day 85
measure: Number of Participants With Remission in Uveitis
timeFrame: Baseline (Day 1) up to Month 8
measure: Number of Participants Who Were Able to Re-induce a Remission if a Flare-up Occurs
timeFrame: Day 1 to Day 57
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Golden
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Littleton
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Atlanta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Cambridge
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Teaneck
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Slingerlands
country: United States
facility: Novartis Investigative Site
state: New York
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Letko E, Yeh S, Foster CS, Pleyer U, Brigell M, Grosskreutz CL; AIN457A2208 Study Group. Efficacy and safety of intravenous secukinumab in noninfectious uveitis requiring steroid-sparing immunosuppressive therapy. Ophthalmology. 2015 May;122(5):939-48. doi: 10.1016/j.ophtha.2014.12.033. Epub 2015 Jan 29.
citation: Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, Antoni C, Draelos Z, Gold MH; Psoriasis Study Group; Durez P, Tak PP, Gomez-Reino JJ; Rheumatoid Arthritis Study Group; Foster CS, Kim RY, Samson CM, Falk NS, Chu DS, Callanan D, Nguyen QD; Uveitis Study Group; Rose K, Haider A, Di Padova F. Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis. Sci Transl Med. 2010 Oct 6;2(52):52ra72. doi: 10.1126/scitranslmed.3001107.