Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: PF-06342674 0.25 mg/kg Biological: Placebo Biological: PF-06342674 1.5 mg/kg Biological: PF-06342674 6.0 mg/kg Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : September 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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

Biological: Placebo
Bi-Weekly Subcutaneous Injections X 6

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

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

Experimental: PF-06342674 6.0 mg/kg (q2 Weeks) Biological: Placebo
Bi-Weekly Subcutaneous Injections X 6

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

Experimental: PF-06342674 6.0 mg/kg (q1 Week) Biological: Placebo
Bi-Weekly Subcutaneous Injections X 6

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Concentration of PF-06342674 [ Time Frame: Baseline through Day 127/Early Termination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045732


Locations
Layout table for location information
United States, New York
Albany Advanced Imaging
Albany, New York, United States, 12205
Fallon Wellness Pharmacy
Latham, New York, United States, 12110
Northeast Eye Center
Latham, New York, United States, 12110
The MS Center of Northeastern New York
Latham, New York, United States, 12110
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Retina Vitreous Center
Edmond, Oklahoma, United States, 73013
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Radiology Associates (X-ray facility only)
Oklahoma City, Oklahoma, United States, 73112
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02045732    
Other Study ID Numbers: B4351002
First Posted: January 27, 2014    Key Record Dates
Results First Posted: January 16, 2017
Last Update Posted: January 16, 2017
Last Verified: November 2016
Keywords provided by Pfizer:
Multiple Sclerosis
MRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases