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A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06342674 0.25 mg/kg
Placebo
PF-06342674 1.5 mg/kg
PF-06342674 6.0 mg/kg
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, MRI

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Women and men aged 18-55 yrs.
  • Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the McDonald Criteria.
  • Expanded Disability Status Scale (EDSS) between 0-5, inclusive.

Exclusion Criteria:

  • Relapse episode of MS within 2 weeks of enrollment.
  • Primary progressive MS without a relapsing component.
  • Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying agents up to 6 weeks prior to enrollment.

Sites / Locations

  • Albany Advanced Imaging
  • Fallon Wellness Pharmacy
  • Northeast Eye Center
  • The MS Center of Northeastern New York
  • Cleveland Clinic
  • Retina Vitreous Center
  • Lynn Health Science Institute
  • Radiology Associates (X-ray facility only)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

PF-06342674 1.5 mg/kg

PF-06342674 6.0 mg/kg (q2 Weeks)

PF-06342674 6.0 mg/kg (q1 Week)

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Number of Treatment-Emergent AEs and SAEs by Severity
AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.
Number of Participants With Clinical Laboratory Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF).
Number of Participants With Clinically Significant Changes in Vital Signs
Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm).
Number of Participants With Abnormal Electrocardiogram (ECG)
Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec.
Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)
Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32.

Secondary Outcome Measures

Concentration of PF-06342674

Full Information

First Posted
January 22, 2014
Last Updated
November 18, 2016
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02045732
Brief Title
A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)
Official Title
A Phase 1b, Double-blinded, Placebo-controlled, Randomized Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Subjects With Multiple Sclerosis (ms)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
This study terminated on April 8, 2015 due to a corporate decision and not related to the safety or efficacy of the protocol.
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Title
PF-06342674 1.5 mg/kg
Arm Type
Experimental
Arm Title
PF-06342674 6.0 mg/kg (q2 Weeks)
Arm Type
Experimental
Arm Title
PF-06342674 6.0 mg/kg (q1 Week)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PF-06342674 0.25 mg/kg
Intervention Description
Bi-Weekly Subcutaneous Injections X 6
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Bi-Weekly Subcutaneous Injections X 6
Intervention Type
Biological
Intervention Name(s)
PF-06342674 1.5 mg/kg
Intervention Description
Bi-Weekly Subcutaneous Injections X 6
Intervention Type
Biological
Intervention Name(s)
PF-06342674 6.0 mg/kg
Intervention Description
Bi-Weekly Subcutaneous Injections X 6
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
Description
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Time Frame
Baseline through Day 127/Early Termination
Title
Number of Treatment-Emergent AEs and SAEs by Severity
Description
AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.
Time Frame
Baseline through Day 127/Early Termination
Title
Number of Participants With Clinical Laboratory Abnormalities
Description
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF).
Time Frame
Baseline through Day 127/Early Termination
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Description
Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm).
Time Frame
Baseline through Day 127/Early Termination
Title
Number of Participants With Abnormal Electrocardiogram (ECG)
Description
Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec.
Time Frame
Baseline through Day 127/Early Termination
Title
Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)
Description
Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32.
Time Frame
Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination
Secondary Outcome Measure Information:
Title
Concentration of PF-06342674
Time Frame
Baseline through Day 127/Early Termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women and men aged 18-55 yrs. Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2010 revision of the McDonald Criteria. Expanded Disability Status Scale (EDSS) between 0-5, inclusive. Exclusion Criteria: Relapse episode of MS within 2 weeks of enrollment. Primary progressive MS without a relapsing component. Intolerant or unwilling to undergo MRI scanning. Treatment with disease modifying agents up to 6 weeks prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Albany Advanced Imaging
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Fallon Wellness Pharmacy
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Northeast Eye Center
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
The MS Center of Northeastern New York
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina Vitreous Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Radiology Associates (X-ray facility only)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4351002&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20PF-06342674%20%28RN168%29%20In%20Subjects%20with%20Multiple%20Sclerosis%20%28MS%29
Description
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A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)

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