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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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ClinicalTrials.gov Identifier: NCT02045732
Recruitment Status : Terminated (This study terminated on April 8, 2015 due to a corporate decision and not related to the safety or efficacy of the protocol.)
First Posted : January 27, 2014
Results First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE January 27, 2014
Results First Submitted Date  ICMJE November 18, 2016
Results First Posted Date  ICMJE January 16, 2017
Last Update Posted Date January 16, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs [ Time Frame: Baseline through Day 127/Early Termination ]
    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 [ Time Frame: Baseline through Day 127/Early Termination ]
    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 [ Time Frame: Baseline through Day 127/Early Termination ]
    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 [ Time Frame: Baseline through Day 127/Early Termination ]
    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) [ Time Frame: Baseline through Day 127/Early Termination ]
    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) [ Time Frame: Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 127 Days ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: 127 Days ]
    Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Concentration of PF-06342674 [ Time Frame: Baseline through Day 127/Early Termination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 127 Days ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 127 Days ]
    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 127 Days ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 127 Days ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 127 Days ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Apparent Oral Clearance (CL/F) [ Time Frame: 127 Days ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Steady-State Volume of Distribution [ Time Frame: 127 Days ]
    Apparent volume of distribution at steady state estimated graphically from trapezoidal total area measurements.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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.
Detailed Description Not 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 Date October 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP