Safety and effectiveness of AIN457 in the treatment of patients with noninfectious uveitis

• Conditions: Intermediate, posterior or pan-uveitis of noninfectious origin; MedDRA version: 14.0Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.0Level: PTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-001243-67-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-27
• Last Update Posted: 2 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

This study has 6 cohorts of patients with noninfectious uveitis. The recruitments for cohorts 1 to 5 are closed. Therefore, patients in Germany can only be recruited in cohort 6 for which principal inclusion criteria are:
1.Male and female subjects age 18 to 75 (inclusive) years of age
2.All female subjects must have negative pregnancy test results at screening and just before each dose
3.Male subjects must agree to use simultaneously two acceptable methods of contraception for the entire duration of the study, up to the study completion visit, unless they have undergone a vasectomy more thans six months prior to first dosing. A vasectomy must be supported with clinical documentation made available to the sponsor and/or Principal Investigator and noted in the Relevant Medical History/Current Medical Conditions sections of the CRF.
4.Able to communicate well with the investigator, to understand and comply with the requirements of the study.
5.Understand and sign the written informed consent.
6.Patients with noninfectious uveitis requiring systemic immunosuppression with prednisone or with agents other than or in addition to prednisone. The forms of uveitis include but are not limited to Behcet`s disease, Vogt-Koyanagi-Harada disease, sarcoidosis, anterior uveitis, intermediate uveitis or pars planitis, posterior uveitis, and panuveitis.
7.At the screening visit and baseline visit, the vitreous haze score must be +1 or worse in the study eye.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

This study has 6 cohorts of patients with noninfectious uveitis. The recruitments for cohorts 1 to 5 are closed. Therefore, patients in Germany can only be recruited in cohort 6 for which principal exclusion criteria are:
1.Participation in any other clinical investigation within 4 weeks prior to Day 1 (or longer if required by local regulation), and for any other limitation of participation based on local regulations.
2.Any concurrent medical condition unrelated to uveitis that requires immunosuppressive or immunomodulatory therapy or that may be exacerbated by immunosuppressive therapies.
3.Body weight greater than 120 kg.
4.Systemic or extraocular disease that would contraindicate long-term immunosuppression, especially infectious diseases such as any active infection within 2 weeks of screening with the exception of the common cold, a history of an infectious disease that can spontaneously re-emerge or that are impossible to completely cure such as tuberculosis, histoplasmosis, toxoplasmosis, malaria, viral hepatitis and HIV/AIDS, a history of on-going, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive PPD skin test or a positive QuantiFERON TB-Gold test. Patients with evidence of latent tuberculosis may enter the trial after evaluation by an appropriate specialist and after sufficient treatment has been initiated according to local regulations or standard of care.
5.Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
6.Significant illness within two weeks prior to dosing.
7.History of clinically significant adverse events to vaccines or other antibodies drugs.
8.History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases.
9.Uveitis that is so severe that, in the investigator`s judgment, it is too risky to test an experimental drug
10.Uveitis with an underlying diagnosis that is uncertain and which would reasonably include a disease for which immunosuppression would be contraindicated or for which immunosuppression is not proven to be beneficial
11.Forms of uveitis that may spontaneously resolve such as acute multifocal placoid pigment epitheliopathy or multiple evanescent white dot syndrome.
12. Oral non-steroidal immunosuppressive drugs are allowed up to the baseline day as long the dose has not changed during the 3 weeks prior to baseline.
13. Any systemic immunosuppressive antibodies given intravenously or subcutaneously
within 4 months prior to Day 1 such as infliximab, daclizumab, etanercept, or
adalimumab, except for Raptiva (efalizumab) and Rituxan (rituximab) which are excluded
for 12 months prior to Day 1.
14. Any previous AIN457 treatment.
15. Periocular or intra-vitreal drugs (e.g., corticosteroids) administered to the study eye within three months prior to Day 1.
16. A Retisert® implant in the study eye within the last 3 years.
17. Use of antibiotic treatment over the 4 weeks prior to screening that cannot safely be discontinued at the screening visit or that is given between the screening visit and the baseline visit.
18. Topical ocular steroid therapy greater than the equivalent of Prednisolone acetate 1% every hour while awake within 1 week of Day 1.
19. Ocular surgery in the study eye within the last 4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified