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| ID | Type | Description | Link |
|---|---|---|---|
| IND #100,184 |
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The purpose of this study is to evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM-093 | Drug | 60 mg, administered subcutaneously, weekly |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of MM-093, as compared to placebo, when administered as a monotherapy once a week for 24 weeks after discontinuing IMT therapy. | ||
| To evaluate the biological activity of MM-093, as compared to placebo, as defined by the proportion of patients who have a relapse in their uveitis after discontinuing IMT therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the time to relapse of uveitis after IMT therapy has been discontinued. | ||
| To evaluate the degree of IMT tapering before a recurrence of uveitis occurs. | ||
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Inclusion Criteria:
Exclusion Criteria:
Significant concurrent medical diseases including:
Autoimmune or connective tissue disorder other than sarcoid or birdshot uveitis, (e.g. Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Scleroderma.)
Other known active eye diseases or eye infections (bacterial, fungal, or viral) that may interfere with the evaluation of uveitis.
Grade 2 or above liver function abnormality
Renal disease
Any previous history of immunodeficiency syndromes or infection with human immunodeficiency virus (HIV), or a history of hepatitis C or chronic hepatitis B.
Live viral or bacterial vaccinations within 3 months prior to screening, or planning to receive such vaccinations during the trial, or up to 3 months after the last injection of MM-093.
Pregnant or breastfeeding women or women planning to become pregnant during the study or within 4 weeks after the last dose of the study drug.
Scheduled elective surgery during study participation
Participated in any previous clinical trials using MM-093 or have any prior exposure to MM-093.
History of severe hypersensitivity to goat, sheep, or cow milk products derived from goat, sheep or cow milk (patients who are lactose intolerant are not excluded.)
Any other acute or clinically important condition that the investigator feels would jeopardize the integrity of the study (e.g. a CTCAE grade 2 or above clinical finding or laboratory result.)
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Stephen Foster | Massachusetts Eye Research and Surgery Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MERSI | Cambridge | Massachusetts | 02142 | United States |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| Other |
Placebo |
|
| To evaluate visual function as evidenced by visual acuity and by electroretinography. |
| To evaluate sub clinical inflammation as measured by fluorescein angiography. |
| To evaluate the formation of anti-MM-093 antibodies after MM-093 administration. |
| To evaluate the formation of anti-goat antibodies after MM-093 administration. |