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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 November 17, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)
Official Title  ICMJE 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)
Brief SummaryPF-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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 18, 2016)
4
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2014)
60
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion DateOctober 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02045732
Other Study ID Numbers  ICMJE B4351002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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