Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01585766 |
Recruitment Status
:
Completed
First Posted
: April 26, 2012
Last Update Posted
: August 16, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis, Relapsing Forms | Biological: MEDI-551 IV Biological: MEDI-551 SC Drug: Placebo IV Drug: Placebo SC | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: MEDI-551 Dosage 1
Dosage Level 1 x 2 MEDI-551 IV
|
Biological: MEDI-551 IV
Associated Dosage Level x 2 MEDI-551 IV
|
Experimental: MEDI-551 Dosage 2
Dosage Level 2 x 2 MEDI-551 IV
|
Biological: MEDI-551 IV
Associated Dosage Level x 2 MEDI-551 IV
|
Experimental: MEDI-551 Dosage 3
Dosage Level 3 x 1 MEDI-551 SC
|
Biological: MEDI-551 SC
Associated Dosage Level X 1 MEDI-551 SC
|
Experimental: MEDI-551 Dosage 4
Dosage Level 4 x 1 MEDI-551 SC
|
Biological: MEDI-551 SC
Associated Dosage Level X 1 MEDI-551 SC
|
Experimental: MEDI-551 Dosage 5
Dosage Level 5 x 2 MEDI-551 IV
|
Biological: MEDI-551 IV
Associated Dosage Level x 2 MEDI-551 IV
|
Placebo Comparator: Placebo IV
Placebo IV x 2
|
Drug: Placebo IV
Placebo IV x 2
|
Placebo Comparator: Placebo SC
Placebo SC x 1
|
Drug: Placebo SC
Placebo SC x 1
|
- Safety and Tolerability [ Time Frame: Day 1 to Day 169 ]To evaluate the safety and tolerability of ascending IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS through the assessment of treatment-emergent adverse events and serious adverse events
- Pharmacokinetics of MEDI-551 [ Time Frame: Day 1 to Day 169 ]To evaluate the pharmacokinetics (PK) of MEDI-551 in the subject population (including but not limited to Cmax, Tmax, T1/2, AUC)
- Pharmacodynamic Effect of MEDI-551 [ Time Frame: Day 1 to Day 169 ]To describe the pharmacodynamic (PD) effects of MEDI-551 as measured by the change in B cell count from baseline
- Immunogenicity of MEDI-551 [ Time Frame: Day 1 to Day 169 ]To evaluate the immunogenicity (IM) of MEDI-551 in the subject population

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed relapsing form of MS (ie, RRMS, SPMS, PRMS, or CIS) according to revised 2010 McDonald criteria and MRI brain lesions consistent with MS on screening
- At least 1 documented relapse within the past 3 years prior to screening
- EDSS between 0.0 and 6.5 at screening
- Have no more than 20 Gd-enhancing T1 brain lesions detected by cranial MRI scan
Exclusion Criteria:
- Subjects with impaired renal function
- Major surgery within 8 weeks of the screening visit
- Subjects who are unable to undergo cranial MRI scan
- A history of hypersensitivity to Gd-containing MRI contrast agents
- Has received within 1 year prior to screening: monoclonal antibodies, experimental B-cell depleting agents, or treatment with natalizumab (Tysabri) for greater than 3 months
- Receiving monthly methylprednisone or equivalent glucocorticoid for disease modification of a relapsing form of MS
- Known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, methylprednisolone or equivalent glucocorticoid, or to any component of the investigational drug
- Diagnosis of PPMS, neuromyelitis optica, or other non-MS variant of neuro-inflammatory or demyelinating diseases
- Any history of opportunistic infection or the presence of active infection within two months prior to screening or any herpes zoster infection that has not resolved within 12 weeks prior to screening
- Any clinically significant findings during the screening phase, including physical, neurological, laboratory, or ECG examination as per protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585766
United States, Arizona | |
Research Site | |
Scottsdale, Arizona, United States | |
United States, California | |
Research Site | |
Long Beach, California, United States | |
Research Site | |
Sacramento, California, United States | |
United States, Colorado | |
Research Site | |
Denver, Colorado, United States | |
United States, Florida | |
Research Site | |
Tampa, Florida, United States | |
United States, New Jersey | |
Research Site | |
Marlton, New Jersey, United States | |
United States, North Carolina | |
Research Site | |
Winston-Salem, North Carolina, United States | |
United States, Tennessee | |
Research Site | |
Cordova, Tennessee, United States | |
United States, Texas | |
Research Site | |
Houston, Texas, United States | |
Poland | |
Research Site | |
Katowice, Poland | |
Research Site | |
Szczecin, Poland | |
Spain | |
Research Site | |
Barcelona, Spain | |
Research Site | |
Girona, Spain | |
Research Site | |
Sevilla, Spain | |
Ukraine | |
Research Site | |
Donetsk, Ukraine | |
Research Site | |
Kyiv, Ukraine |
Study Director: | Armando Flor | MedImmune LLC |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT01585766 History of Changes |
Other Study ID Numbers: |
CD-IA-MEDI-551-1102 |
First Posted: | April 26, 2012 Key Record Dates |
Last Update Posted: | August 16, 2016 |
Last Verified: | August 2016 |
Keywords provided by MedImmune LLC:
MAb, B cell, depletion, RMS |
Additional relevant MeSH terms:
Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |