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

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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)

ClinicalTrials.gov ID

NCT02045732

Acronym / sponsor ID

B4351002

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, MRI

Phase

Phase 1

Study type

Interventional

Recruitment status

TerminatedReason stopped: This study terminated on April 8, 2015 due to a corporate decision and not related to the safety or efficacy of the protocol.

Enrolment

4 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

Sep 2014

Primary completion

Oct 2015 (actual)

Study completion

Oct 2015 (actual)

First posted

27 Jan 2014 (estimated)

Results

Posted 16 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Single group

Masking

Double blind (participant, investigator)

Number of arms

4

Who may qualify

Ages

18 to 55 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

8 sites in 1 country: see every site and its status.