Multiple Sclerosis, Relapsing FormsPhase 1NCT01585766
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
A Phase 1 study testing MEDI-551 30 MG-IV, MEDI-551 60 MG-SC and MEDI-551 100 MG-IV in people with Multiple Sclerosis, Relapsing Forms, run by MedImmune LLC at 16 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing Forms
- What is being tested?
- MEDI-551 30 MG-IV, MEDI-551 60 MG-SC and MEDI-551 100 MG-IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 24 Apr 2012to 20 Jun 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
United States9 sites
Research Site
Cordova, Tennessee
Research Site
Denver, Colorado
Research Site
Houston, Texas
Research Site
Long Beach, California
Research Site
Marlton, New Jersey
Research Site
Sacramento, California
Research Site
Scottsdale, Arizona
Research Site
Tampa, Florida
Research Site
Winston-Salem, North Carolina
About this study
Official title: A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).
Read the detailed description
This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.
- Conditions
- Multiple Sclerosis, Relapsing Forms
- Being tested
- MEDI-551 30 MG-IV, MEDI-551 60 MG-SC, PLACEBO-IV-SC, MEDI-551 100 MG-IV, MEDI-551 300 MG-SC
- Keywords
- MAb, B cell, depletion, RMS
- Medical subject headings
- Multiple Sclerosis, Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-551 30 MG-IVDrug
Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
MEDI-551 60 MG-SCDrug
Participants received SC injection of 60 mg MEDI-551 on Day 1.
PLACEBO-IV-SCDrug
Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1
MEDI-551 100 MG-IVDrug
Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
MEDI-551 300 MG-SCDrug
Participants received SC injection of 300 mg MEDI-551 on Day 1.
MEDI-551 600 MG-IVDrug
Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
| Study group | Role | What they receive |
|---|---|---|
| MEDI-551 30 MG-IV | Experimental | Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. Receives: Drug: MEDI-551 30 MG-IV |
| MEDI-551 60 MG-SC | Experimental | Participants received SC injection of 60 mg MEDI-551 on Day 1. Receives: Drug: MEDI-551 60 MG-SC |
| MEDI-551 100 MG-IV | Experimental | Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. Receives: Drug: MEDI-551 100 MG-IV |
| MEDI-551 300 MG-SC | Experimental | Participants received SC injection of 300 mg MEDI-551 on Day 1. Receives: Drug: MEDI-551 300 MG-SC |
| MEDI-551 600 MG-IV | Experimental | Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. Receives: Drug: MEDI-551 600 MG-IV |
| PLACEBO-IV-SC | Placebo comparator | Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1. Receives: Drug: PLACEBO-IV-SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Measured: From study drug administration (Day 1) through the end of treatment period (Day 169)
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect in the offspring of a participant who received the study drug. The TESAEs were the events between administration of study drug (Day 1) and long term follow up period (up to 18 months after early discontinuation visit or 24-week treatment period) that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Measured: From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Any clinically significant change in laboratory evaluations were recorded as AEs. The following parameters were analyzed for laboratory evaluations: haematology, serum chemistry, and urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.
Measured: From study drug administration (Day 1) through the end of treatment period (Day 169)
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. The number of participants with TEAEs related to vital signs in participants were reported.
Measured: From study drug administration (Day 1) through the end of treatment period (Day 169)
Secondary outcomes (13)
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-551
The time to reach the maximum observed serum concentration of MEDI-551.
Measured: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Maximum Observed Serum Concentration (Cmax) of MEDI-551
The maximum observed serum concentration (Cmax) of MEDI-551.
Measured: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-last) of MEDI-551
The area under the concentration time curve from time 0 (dosing time) to the last measurable concentration (AUC 0-last) of MEDI-551.
Measured: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity) of MEDI-551
The area under the concentration-time curve from dosing extrapolated to infinity (AUC 0-infinity) of MEDI-551.
Measured: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Dose Normalized Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity/D) of MEDI-551
The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity post dose normalized by MEDI-551.
Measured: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Clearance of MEDI-551
Systemic clearance (CL) for MEDI-551 IV cohorts and apparent clearance (CL/F) for MEDI-551 SC cohorts were calculated
Measured: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Terminal Elimination Half-life (t1/2) of MEDI-551
The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI-551.
Measured: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Absolute Subcutaneous Bioavailability (F%) of MEDI-551
Bioavailability (F%) is the fraction of the study drug absorbed through non-intravenous administration compared with the corresponding intravenous administration of the same drug.
Measured: Predose (Day 1) and Days 4, 8, 15, 29, 57, 85, 113, 141, and 169
Absolute CD20 B-cell Count at Baseline
Baseline absolute CD20 count is measured as the average between screening and predose on Day 1.
Measured: Baseline (Days -28 to -1)
Time to 90 Percent (%) CD20 B-cell Depletion
Time in days of first observation where CD20 counts fall to or below 10 percent (%) of baseline.
Measured: Baseline (Days -28 to -1) to long-term follow-up (LTFU) (Up to 18 months after EDV or 24 Week treatment period)
Duration of Suppression Greater Than or Equal to 90 % of CD20 B-cell Count
Time in days of last observation where CD20 counts remain at or below 10% of baseline. Participants whose samples are available were analyzed for this outcome measure.
Measured: Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)
Maximum Change From Baseline in Absolute CD20 of Peripheral Blood B-cell Count to LTFU
The maximum degree of depletion (intensity) measured during the course of the study for each participant by subtracting 100 from the lowest observed percent of baseline value.
Measured: Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)
Number of Participants Positive for Anti-Drug Antibodies to MEDI-551
A participant was considered anti-drug antibody positive across the study if they had a positive reading at any time point during the study.
Measured: Days 1, 29, 85 and 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study start24 Apr 2012
- Primary completion2 Jan 2015
- Study completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Sclerosis, Relapsing FormsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armando Flor, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585766
- Sponsor's protocol ID
- CD-IA-MEDI-551-1102
- Status last verified
- Feb 2018
- First submitted
- 9 Apr 2012
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized Study of MEDI-551 in Subjects With Relapsing Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01585766
- Acronym / sponsor ID
- CD-IA-MEDI-551-1102
- Conditions
- Multiple Sclerosis, Relapsing Forms
- Keywords
- MAb, B cell, depletion, RMS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2012 (actual)
- Primary completion
- 2 Jan 2015 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 29 Oct 2018
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 safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).
Detailed description
This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MEDI-551 30 MG-IV | Experimental | Drug: MEDI-551 30 MG-IVParticipants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. |
| MEDI-551 60 MG-SC | Experimental | Drug: MEDI-551 60 MG-SCParticipants received SC injection of 60 mg MEDI-551 on Day 1. |
| MEDI-551 100 MG-IV | Experimental | Drug: MEDI-551 100 MG-IVParticipants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. |
| MEDI-551 300 MG-SC | Experimental | Drug: MEDI-551 300 MG-SCParticipants received SC injection of 300 mg MEDI-551 on Day 1. |
| MEDI-551 600 MG-IV | Experimental | Drug: MEDI-551 600 MG-IVParticipants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. |
| PLACEBO-IV-SC | Placebo comparator | Drug: PLACEBO-IV-SCParticipants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| MEDI-551 30 MG-IVParticipants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. | Drug | MEDI-551 30 MG-IV |
| MEDI-551 60 MG-SCParticipants received SC injection of 60 mg MEDI-551 on Day 1. | Drug | MEDI-551 60 MG-SC |
| PLACEBO-IV-SCParticipants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1 | Drug | PLACEBO-IV-SC |
| MEDI-551 100 MG-IVParticipants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. | Drug | MEDI-551 100 MG-IV |
| MEDI-551 300 MG-SCParticipants received SC injection of 300 mg MEDI-551 on Day 1. | Drug | MEDI-551 300 MG-SC |
| MEDI-551 600 MG-IVParticipants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. | Drug | MEDI-551 600 MG-IV |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From study drug administration (Day 1) through the end of treatment period (Day 169)
An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect in the offspring of a participant who received the study drug. The TESAEs were the events between administration of study drug (Day 1) and long term follow up period (up to 18 months after early discontinuation visit or 24-week treatment period) that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Time frame: From study drug administration (Day 1) through the end of treatment period (Day 169)
Any clinically significant change in laboratory evaluations were recorded as AEs. The following parameters were analyzed for laboratory evaluations: haematology, serum chemistry, and urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.
Number of Participants With Vital Sign Abnormalities Reported as TEAEs
Time frame: From study drug administration (Day 1) through the end of treatment period (Day 169)
Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. The number of participants with TEAEs related to vital signs in participants were reported.
13 secondary outcomes
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-551
Time frame: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Maximum Observed Serum Concentration (Cmax) of MEDI-551
Time frame: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-last) of MEDI-551
Time frame: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity) of MEDI-551
Time frame: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Dose Normalized Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity/D) of MEDI-551
Time frame: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Clearance of MEDI-551
Time frame: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Terminal Elimination Half-life (t1/2) of MEDI-551
Time frame: Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169
Absolute Subcutaneous Bioavailability (F%) of MEDI-551
Time frame: Predose (Day 1) and Days 4, 8, 15, 29, 57, 85, 113, 141, and 169
Absolute CD20 B-cell Count at Baseline
Time frame: Baseline (Days -28 to -1)
Time to 90 Percent (%) CD20 B-cell Depletion
Time frame: Baseline (Days -28 to -1) to long-term follow-up (LTFU) (Up to 18 months after EDV or 24 Week treatment period)
Duration of Suppression Greater Than or Equal to 90 % of CD20 B-cell Count
Time frame: Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)
Maximum Change From Baseline in Absolute CD20 of Peripheral Blood B-cell Count to LTFU
Time frame: Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)
Number of Participants Positive for Anti-Drug Antibodies to MEDI-551
Time frame: Days 1, 29, 85 and 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Armando Flor study director
MedImmune LLC
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-551 30 MG-IV, MEDI-551 60 MG-SC and MEDI-551 100 MG-IV in people with Multiple Sclerosis, Relapsing Forms, run by MedImmune LLC at 16 sites in 4 countries.
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 4 inclusion and 10 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Spain, Poland, Ukraine. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From study drug administration (Day 1) through the end of treatment period (Day 169)). The study lists 4 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 29 Oct 2018.