NCT02045732

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)

Terminated Phase 1 Results posted Last updated 18 November 2016

What this trial tests

Phase 1 trial testing PF-06342674 0.25 mg/kg in Multiple Sclerosis in 4 participants. Terminated before completion.

Timeline

1 September 2014

Primary endpoint
1 October 2015

1 October 2015

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	4
Start date	1 September 2014
Primary completion	1 October 2015
Estimated completion	1 October 2015
Sites	8 locations across United States

Drugs / interventions tested

• PF-06342674 0.25 mg/kg — full drug profile →
• Placebo
• PF-06342674 1.5 mg/kg — full drug profile →
• PF-06342674 6.0 mg/kg — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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.
• 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 (q
• 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).
• 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.
• 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 a

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current and emerging disease-modulatory therapies and treatment targets for multiple sclerosis.
   Piehl F. · · 2021 · cited 71× · PMID 33258193 · DOI 10.1111/joim.13215
2. Anti-IL-7 receptor α monoclonal antibody (GSK2618960) in healthy subjects - a randomized, double-blind, placebo-controlled study.
   Ellis J, van Maurik A, Fortunato L, Gisbert S, et al · · 2019 · cited 38× · PMID 30161291 · DOI 10.1111/bcp.13748
3. Targeting memory T cells in type 1 diabetes.
   Ehlers MR, Rigby MR. · · 2015 · cited 35× · PMID 26370695 · DOI 10.1007/s11892-015-0659-5
4. Neuroimmunotherapies Targeting T Cells: From Pathophysiology to Therapeutic Applications.
   Bittner S, Wiendl H. · · 2016 · cited 24× · PMID 26563391 · DOI 10.1007/s13311-015-0405-3
5. Modulation of peripheral T-cell function by interleukin-7 in rheumatoid arthritis.
   Churchman SM, El-Jawhari JJ, Burska AN, Parmar R, et al · · 2014 · cited 18× · PMID 25533722 · DOI 10.1186/s13075-014-0511-3
6. Targeting Homeostatic T Cell Proliferation to Control Beta-Cell Autoimmunity.
   Vignali D, Monti P. · · 2016 · cited 10× · PMID 26983628 · DOI 10.1007/s11892-016-0731-9
7. Targeting γc family cytokines with biologics: current status and future prospects.
   Bick F, Blanchetot C, Lambrecht BN, Schuijs MJ. · · 2025 · cited 5× · PMID 39967341 · DOI 10.1080/19420862.2025.2468312
8. Combining anti-IL-7Rα antibodies with autoantigen-specific immunotherapy enhances non-specific cytokine production but fails to prevent Type 1 Diabetes.
   Vazquez-Mateo C, Collins J, Goldberg SJ, Lawson M, et al · · 2019 · cited 3× · PMID 30908554 · DOI 10.1371/journal.pone.0214379