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

NCT02045732 | Terminated Phase 1 Results

• 1 other identifier: B4351002
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 8

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MRI

Outcome Measures

Primary Outcomes (6)

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

  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.

  Baseline through Day 127/Early Termination

• Number of Treatment-Emergent AEs and SAEs by Severity

  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.

  Baseline through Day 127/Early Termination

• Number of Participants With Clinical Laboratory Abnormalities

  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).

  Baseline through Day 127/Early Termination

• Number of Participants With Clinically Significant Changes in Vital Signs

  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).

  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 Outcomes (1)

• Concentration of PF-06342674

  Baseline through Day 127/Early Termination

Study Arms (4)

Cohort 1

EXPERIMENTAL

Biological: PF-06342674 0.25 mg/kg; Biological: Placebo

PF-06342674 1.5 mg/kg

EXPERIMENTAL

Biological: Placebo; Biological: PF-06342674 1.5 mg/kg

PF-06342674 6.0 mg/kg (q2 Weeks)

EXPERIMENTAL

Biological: Placebo; Biological: PF-06342674 6.0 mg/kg

PF-06342674 6.0 mg/kg (q1 Week)

EXPERIMENTAL

Biological: Placebo; Biological: PF-06342674 6.0 mg/kg

Interventions

PF-06342674 0.25 mg/kg BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

Cohort 1

Placebo BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

Cohort 1; PF-06342674 1.5 mg/kg; PF-06342674 6.0 mg/kg (q1 Week); PF-06342674 6.0 mg/kg (q2 Weeks)

PF-06342674 1.5 mg/kg BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 1.5 mg/kg

PF-06342674 6.0 mg/kg BIOLOGICAL

Bi-Weekly Subcutaneous Injections X 6

PF-06342674 6.0 mg/kg (q1 Week); PF-06342674 6.0 mg/kg (q2 Weeks)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Albany Advanced Imaging

Albany, New York, 12205, United States

Location

Fallon Wellness Pharmacy

Latham, New York, 12110, United States

Location

Northeast Eye Center

Latham, New York, 12110, United States

Location

The MS Center of Northeastern New York

Latham, New York, 12110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Retina Vitreous Center

Edmond, Oklahoma, 73013, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Radiology Associates (X-ray facility only)

Oklahoma City, Oklahoma, 73112, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

monoclonal antibody RN168

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Due to the early termination of the study, the small enrollment number and minimal data, no statistical analyses were performed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 27, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

US (8)