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

Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02045732
• Other study ID #: B4351002
• Status: Terminated
• Phase: Phase 1
• First received: January 22, 2014
• Last updated: March 30, 2016
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• PF-06342674 0.25 mg/kg
Bi-Weekly Subcutaneous Injections X 6
• Placebo
Bi-Weekly Subcutaneous Injections X 6
• PF-06342674 1.5 mg/kg
Bi-Weekly Subcutaneous Injections X 6
• PF-06342674 6.0 mg/kg
Bi-Weekly Subcutaneous Injections X 6

Locations

Country	Name	City	State
United States	Albany Advanced Imaging	Albany	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Edmond	Oklahoma
United States	Retina Vitreous Center	Edmond	Oklahoma
United States	Fallon Wellness Pharmacy	Latham	New York
United States	Northeast Eye Center	Latham	New York
United States	The MS Center of Northeastern New York	Latham	New York
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Radiology Associates (X-ray facility only)	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	127 Days	Yes
Primary	Number of Participants With Laboratory Test Values of Potential Clinical Importance	Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.	127 Days	Yes
Secondary	Area Under the Curve from Time Zero to end of dosing interval (AUCtau)		127 Days	No
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	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).	127 Days	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		127 Days	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		127 Days	No
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	127 Days	No
Secondary	Apparent Oral Clearance (CL/F)	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.	127 Days	No
Secondary	Steady-State Volume of Distribution	Apparent volume of distribution at steady state estimated graphically from trapezoidal total area measurements.	127 Days	No

External Links

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