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

Phase 1

Terminated

Conditions: Multiple Sclerosis

Interventions: Biological: PF-06342674 0.25 mg/kg
Biological: Placebo
Biological: PF-06342674 6.0 mg/kg
Biological: PF-06342674 1.5 mg/kg

Registration Number: NCT02045732

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	PF-06342674 0.25 mg/kg	-
PF-06342674 6.0 mg/kg (q2 Weeks)	PF-06342674 6.0 mg/kg	-
PF-06342674 6.0 mg/kg (q1 Week)	Placebo	-
Cohort 1	Placebo	-
PF-06342674 1.5 mg/kg	Placebo	-
PF-06342674 1.5 mg/kg	PF-06342674 1.5 mg/kg	-
PF-06342674 6.0 mg/kg (q2 Weeks)	Placebo	-
PF-06342674 6.0 mg/kg (q1 Week)	PF-06342674 6.0 mg/kg	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs	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	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	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	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)	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)	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

Name	Time	Method
Concentration of PF-06342674	Baseline through Day 127/Early Termination

Trial Locations

Locations (8): Albany Advanced Imaging
🇺🇸
Albany, New York, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Fallon Wellness Pharmacy
🇺🇸
Latham, New York, United States
Northeast Eye Center
🇺🇸
Latham, New York, United States
Retina Vitreous Center
🇺🇸
Edmond, Oklahoma, United States
The MS Center of Northeastern New York
🇺🇸
Latham, New York, United States
Lynn Health Science Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Radiology Associates (X-ray facility only)
🇺🇸
Oklahoma City, Oklahoma, United States