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Terminated
This study terminated on April 8, 2015 due to a corporate decision and not related to the safety or efficacy of the protocol.

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

ClinicalTrials.gov ID NCT02045732
Sponsor Pfizer
Information provided by Pfizer (Responsible Party)
Last Update Posted 2017-01-16
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Study Overview

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.
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)
Conditions
Multiple Sclerosis
Intervention / Treatment
  • Biological: PF-06342674 0.25 mg/kg
  • Biological: Placebo
  • Biological: PF-06342674 1.5 mg/kg
  • Biological: PF-06342674 6.0 mg/kg
  • Biological: PF-06342674 0.25 mg/kg
  • Biological: Placebo
  • Biological: PF-06342674 1.5 mg/kg
  • Biological: PF-06342674 6.0 mg/kg
Other Study ID Numbers
  • B4351002
Study Start
2014-09
Primary Completion (Actual)
2015-10
Study Completion (Actual)
2015-10
Enrollment (Actual)
4
Study Type
Interventional
Phase
Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
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Ages Eligible for Study
18 Years to 55 Years (Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Single Group Assignment
Masking : Double (ParticipantInvestigator)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Cohort 1 Intervention/Treatment Biological: PF-06342674 0.25 mg/kg
  • Bi-Weekly Subcutaneous Injections X 6

Biological: Placebo
  • Bi-Weekly Subcutaneous Injections X 6

Participant Group/Arm Experimental: PF-06342674 1.5 mg/kg Intervention/Treatment Biological: Placebo
  • Bi-Weekly Subcutaneous Injections X 6

Biological: PF-06342674 1.5 mg/kg
  • Bi-Weekly Subcutaneous Injections X 6

Participant Group/Arm Experimental: PF-06342674 6.0 mg/kg (q2 Weeks) Intervention/Treatment Biological: Placebo
  • Bi-Weekly Subcutaneous Injections X 6

Biological: PF-06342674 6.0 mg/kg
  • Bi-Weekly Subcutaneous Injections X 6

Participant Group/Arm Experimental: PF-06342674 6.0 mg/kg (q1 Week) Intervention/Treatment Biological: Placebo
  • Bi-Weekly Subcutaneous Injections X 6

Biological: PF-06342674 6.0 mg/kg
  • Bi-Weekly Subcutaneous Injections X 6

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEsAn 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.Baseline through Day 127/Early Termination
Number of Treatment-Emergent AEs and SAEs by SeverityAE 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.Baseline through Day 127/Early Termination
Number of Participants With Clinical Laboratory AbnormalitiesNumber 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).Baseline through Day 127/Early Termination
Number of Participants With Clinically Significant Changes in Vital SignsCategorical 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).Baseline through Day 127/Early Termination
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.Baseline through Day 127/Early Termination
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.Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Concentration of PF-06342674 Baseline through Day 127/Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Pfizer
Investigators
  • Study Director:Pfizer CT.gov Call Center,Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2014-01-22
First Submitted that Met QC Criteria
2014-01-22
First Posted (Estimated)
2014-01-27
Results Reporting Dates
Results First Submitted
2016-11-18
Results First Submitted that Met QC Criteria
2016-11-18
Results First Posted (Estimated)
2017-01-16
Study Record Updates
Last Update Submitted that met QC Criteria
2016-11-18
Last Update Posted (Estimated)
2017-01-16
Last Verified
2016-11

More Information

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Keywords Provided by Pfizer
Additional Relevant MeSH Terms