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

This study has been completed.
Sponsor:
Information provided by:
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00444743
First received: March 7, 2007
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Uveitis
Drug: MM-093
Other: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.
  • 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.

Estimated Enrollment: 20
Study Start Date: February 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: MM-093
60 mg, administered subcutaneously, weekly
Placebo Comparator: 2 Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444743

Locations
United States, Massachusetts
MERSI
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Principal Investigator: Dr. Stephen Foster Massachusetts Eye Research and Surgery Institute
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00444743     History of Changes
Other Study ID Numbers: MM-093-03-200, IND #100,184
Study First Received: March 7, 2007
Last Updated: December 16, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on October 01, 2014