UveitisPhase 2NCT00444743
Phase 2 Study of MM-093 to Treat Patients With Uveitis
A Phase 2 study testing MM-093 in people with Uveitis, run by Merrimack Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- MM-093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Uveitis
- Being tested
- MM-093, Placebo
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-093Drug
60 mg, administered subcutaneously, weekly
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: MM-093 |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (6)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Stephen Foster, Principal investigator, Massachusetts Eye Research and Surgery Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444743
- Sponsor's protocol ID
- MM-093-03-200
- Other IDs
- IND #100,184
- Status last verified
- Dec 2008
- First submitted
- 7 Mar 2007
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00444743
- Acronym / sponsor ID
- MM-093-03-200
- Conditions
- Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2008 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MM-093 |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM-09360 mg, administered subcutaneously, weekly | Drug | 1 |
| PlaceboPlacebo | Other | 2 |
Primary outcome
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.
6 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2008.
Related trials for Uveitis
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruiting
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis
RecruitingObservational study
A Study of Uveitis in Children <18 Years of Age
Uveitis
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
RecruitingPhase 1
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
Non Infectious Uveitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Stephen Foster principal investigator
Massachusetts Eye Research and Surgery Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MM-093 in people with Uveitis, run by Merrimack Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008.