Phase 2 Study of MM-093 to Treat Patients With Uveitis

Uveitis Clinical Trial

Official title:

A Phase 2, Double - Blind, Placebo - Controlled, Randomized Study to Evaluate the Tolerability, Pharmacokinetics, Pharmacodynamics, and Biologic Activity of MM-093 in Patients With Moderate to Severe Uveitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444743
• Other study ID #: MM-093-03-200
• Secondary ID: IND #100,184
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: December 16, 2008
• Start date: February 2007

Study information

• Verified date: December 2008
• Source: Merrimack Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years and above

• Understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol - specific procedures being performed.

• Have been diagnosed with sarcoid or birdshot uveitis

• Be able and willing to comply with study visits and procedures per protocol.

• Women of child bearing potential must use medically acceptable means of birth control in an effective manner and agree to continue its use during the study and 6 weeks after the last dose of study drug.

• Sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 4 weeks after the last dose of study drug.

• Able to store patient kit/cooler containing study drug in a refrigerator at home.

Exclusion Criteria:

• Significant concurrent medical diseases including:

• Cancer or history of cancer, or lymphoproliferative disorder (other than sarcoidosis or successfully resected cutaneous basal or squamous cell carcinoma) within 5 years before the screening visit.

• Any condition for which participation in this study is judged by the physician to be detrimental to the patient, such as history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric disease.

• Significant ongoing infection requiring systemic antibiotic, antifungal, antiviral, or ant anti-mycobacterial therapy.

• 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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• MM-093
60 mg, administered subcutaneously, weekly

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	MERSI	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Merrimack Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	To evaluate the time to relapse of uveitis after IMT therapy has been discontinued.
Secondary	To evaluate the degree of IMT tapering before a recurrence of uveitis occurs.
Secondary	To evaluate visual function as evidenced by visual acuity and by electroretinography.
Secondary	To evaluate sub clinical inflammation as measured by fluorescein angiography.
Secondary	To evaluate the formation of anti-MM-093 antibodies after MM-093 administration.
Secondary	To evaluate the formation of anti-goat antibodies after MM-093 administration.