Clinical trial NCT02045732: A Study To Evaluate The Safety And Tolerability Of PF-06342674 (RN168) In Subjects With Multiple Sclerosis (MS)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MRI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs
timeFrame: Baseline through Day 127/Early Termination
measure: Number of Treatment-Emergent AEs and SAEs by Severity
timeFrame: Baseline through Day 127/Early Termination
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Baseline through Day 127/Early Termination
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Baseline through Day 127/Early Termination
measure: Number of Participants With Abnormal Electrocardiogram (ECG)
timeFrame: Baseline through Day 127/Early Termination
measure: Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)
timeFrame: Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination
Secondary outcomes:
measure: Concentration of PF-06342674
timeFrame: Baseline through Day 127/Early Termination
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Advanced Imaging
state: New York
city: Latham
country: United States
facility: Fallon Wellness Pharmacy
state: New York
city: Latham
country: United States
facility: Northeast Eye Center
state: New York
city: Latham
country: United States
facility: The MS Center of Northeastern New York
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Radiology Associates (X-ray facility only)
state: Oklahoma
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: