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

Last updated on August 9, 2018

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Study Location
Albany Advanced Imaging
Albany, New York, 12205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02045732
Pfizer
Terminated
A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)

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A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)
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)
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Biological: PF-06342674 0.25 mg/kg
    Bi-Weekly Subcutaneous Injections X 6
  • Biological: Placebo
    Bi-Weekly Subcutaneous Injections X 6
  • Biological: PF-06342674 1.5 mg/kg
    Bi-Weekly Subcutaneous Injections X 6
  • Biological: PF-06342674 6.0 mg/kg
    Bi-Weekly Subcutaneous Injections X 6
  • Experimental: Cohort 1
    Interventions:
    • Biological: PF-06342674 0.25 mg/kg
    • Biological: Placebo
  • Experimental: PF-06342674 1.5 mg/kg
    Interventions:
    • Biological: Placebo
    • Biological: PF-06342674 1.5 mg/kg
  • Experimental: PF-06342674 6.0 mg/kg (q2 Weeks)
    Interventions:
    • Biological: Placebo
    • Biological: PF-06342674 6.0 mg/kg
  • Experimental: PF-06342674 6.0 mg/kg (q1 Week)
    Interventions:
    • Biological: Placebo
    • Biological: PF-06342674 6.0 mg/kg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
October 2015
October 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02045732
B4351002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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