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

NCT ID: NCT02045732

Last Updated: 2017-01-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

PF-06342674 0.25 mg/kg

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

Placebo

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 1.5 mg/kg

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 1.5 mg/kg

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 6.0 mg/kg (q2 Weeks)

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 6.0 mg/kg

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 6.0 mg/kg (q1 Week)

Group Type EXPERIMENTAL

Placebo

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 6.0 mg/kg

Intervention Type BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

Interventions

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PF-06342674 0.25 mg/kg

Bi-Weekly Subcutaneous Injections X 6

Intervention Type BIOLOGICAL

Placebo

Bi-Weekly Subcutaneous Injections X 6

Intervention Type BIOLOGICAL

PF-06342674 1.5 mg/kg

Bi-Weekly Subcutaneous Injections X 6

Intervention Type BIOLOGICAL

PF-06342674 6.0 mg/kg

Bi-Weekly Subcutaneous Injections X 6

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Albany Advanced Imaging

Albany, New York, United States

Site Status

Fallon Wellness Pharmacy

Latham, New York, United States

Site Status

Northeast Eye Center

Latham, New York, United States

Site Status

The MS Center of Northeastern New York

Latham, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Retina Vitreous Center

Edmond, Oklahoma, United States

Site Status

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Radiology Associates (X-ray facility only)

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B4351002

Identifier Type: -

Identifier Source: org_study_id

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