A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Centre, Dose-Ranging Study with an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Anterior Uveitis.
- Conditions
- Subjects with active sight-threatening, non-infectious anterior uveitis who require systemic immunosuppression for control of their disease.MedDRA version: 8.1 Level: LLT Classification code 10046851 Term: Uveitis
- Registration Number
- EUCTR2006-006545-13-GB
- Lead Sponsor
- ux Biosciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
• Subjects with a documented history of non-infectious anterior, anterior and intermediate, or pan-uveitis
• Uncontrolled uveitis, as evidenced by Grade 2+ or higher anterior chamber cells, in at least one eye for = 2 weeks prior to randomization
• In subjects whose diagnosis is not exclusively anterior uveitis, the predominant manifestation of their condition at the time of enrollment must be anterior segment inflammation
• Current uveitis therapy must conform to one of the following:
• Prednisone monotherapy at a dose of = 10 mg/day (or equivalent) for = 2 weeks prior to randomization
• Have received = 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
• Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
• Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
• Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy
• Considered by the Investigator to require immunomodulatory therapy
• Subject does not plan to undergo elective ocular surgery (e.g., cataract extraction) during the study
• A minimum ability to count fingers at a distance of 30 cm (1 foot) using the study eye
• At least 18 years of age
• Subjects, whether male or female, with reproductive potential and who are sexually active agree to use double-barrier contraception methods throughout the course of the study (minimum of 24 weeks) and throughout the extension phase
• Women of childbearing potential must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug and must not be lactating
• Female subjects of non-childbearing potential must meet at least one of the following criteria:
• Be over the age of 60 years
• Be amenorrheic for at least 2 years if age 45-60 years
• Have had a hysterectomy and/or bilateral oophorectomy
All other female subjects (including those with tubal ligations) will be considered to be of childbearing potential
• Subjects must weigh at least 38 kg (84 lbs) and no more than 110 kg (242 lbs) (Note: this restriction is imposed to allow for the masking of treatment assignments.)
• Subjects or their guardians must be:
• Capable of understanding the purpose and risks of the study
• Able to give informed consent (and assent by pediatric subjects, if required)
• Able to comply with the study requirements
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age ran
• Uveitis of infectious etiology
• Clinically suspected or confirmed central nervous system or ocular lymphoma
• Uncontrolled glaucoma, as evidenced by an intraocular pressure of > 21 mmHg while on medical therapy
• Subjects with chronic hypotony (less than 6 mmHg)
• Any implantable corticosteroid-eluting device (e.g., Retisert™, Posurdex®, Medidur™, I-vation™ TA intravitreal implant)
• Treatment with an immune suppression regimen that includes an alkylating agent within the previous 90 days
• Subjects who have received treatment with a monoclonal antibody or any other biologic therapy within the previous 30 days or alemtuzumab within the previous 12 months
• Subjects who have used any drugs or substances known to be strong inhibitors of CYP 3A4/5 enzymes within 7 days of the first dose, or grapefruit juice and star fruit within 24 hours of the first dose
• Subjects who have taken any other medications listed in Section 9.7 of the protocol, within the timeframe specified, prior to the first dose
• Presence of an ocular toxoplasmosis scar
• A known history or clinical diagnosis of herpes zoster or varicella infection within 6 weeks before enrollment, or chicken pox exposure within 21 days before to enrollment
• Seropositivity for human immunodeficiency virus (HIV)
• Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) = 3x upper limit of normal
• Previous exposure or known contraindication to administration of LX211 (ISA247) or any of its components (vitamin E, medium chain triglyceride [MCT] oil, polysorbate 40, ethanol)
• Recipients of a solid organ transplant
• Currently enrolled in another clinical therapeutic trial or who have received any investigational therapy within the 30 days prior to enrollment and/or has not recovered from any reversible effects or side effects of prior investigational agent
• Using a therapy that would likely affect immune responses or interfere with trial logistics
• Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the presence of active hepatitis A, B or C (HAV, HBV, HCV)
• Subjects who have a history of or exposure to syphilis or Lyme disease
• Modification of Diet in Renal Disease Study (MDRD) glomerular filtration rate (GFR) < 60 mL/min
• Severe anemia (hemoglobin < 6 g/dL), leukopenia (white blood cell count < 2500/mm3), thrombocytopenia (platelet count < 80,000/mm3), polycythemia (hematocrit > 54% [male] or hematocrit > 49% [female]) or clinically significant coagulopathy
• Current malignancy or a history of malignancy (within the previous 5 years) except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully
• Subjects with any non-ocular, medically significant co-morbid conditions that impair normal activities, require immunosuppression, or any medical condition that would likely have an impact on the participant’s ability to comply with the study visit schedule
• Currently pregnant or lactating
•
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method