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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Multiple Sclerosis

Treatments: Biological: PF-06342674 0.25 mg/kg; Biological: PF-06342674 1.5 mg/kg; Biological: PF-06342674 6.0 mg/kg; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045732

B4351002

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

4 participants in 4 patient groups

Cohort 1

Experimental group

Treatment:

Biological: PF-06342674 0.25 mg/kg

Biological: Placebo

PF-06342674 1.5 mg/kg

Experimental group

Treatment:

Biological: PF-06342674 1.5 mg/kg

Biological: Placebo

PF-06342674 6.0 mg/kg (q2 Weeks)

Experimental group

Treatment:

Biological: PF-06342674 6.0 mg/kg

Biological: Placebo

PF-06342674 6.0 mg/kg (q1 Week)

Experimental group

Treatment:

Biological: PF-06342674 6.0 mg/kg

Biological: Placebo