A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis

Amgen

Status and phase: Completed; Phase 1

Conditions: Adult Onset Rheumatoid Arthritis

Treatments: Drug: VIB4920; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02780388

2015-005318-30 (EudraCT Number)

D5100C00002

Details and patient eligibility

About

The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (RA).

Full description

Study with completed results acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Enrollment: 57 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult-onset rheumatoid arthritis
• swollen and tender joints

Exclusion criteria

• venous thromboembolism or arterial thrombosis
• pregnant or breastfeeding
• positive hepatitis B, hepatitis C, and human immunodeficiency virus infection
• active or untreated latent tuberculosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive a single intravascular (IV) dose of placebo matched to VIB4920 (formerly MEDI4920) once every 2 weeks (Q2W) from Day 1 up to 12 weeks.

Treatment:

Other: Placebo

VIB4920 75 mg

Experimental group

Description:

Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.

Treatment:

Drug: VIB4920

VIB4920 500 mg

Experimental group

Description:

Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.

Treatment:

Drug: VIB4920

VIB4920 1000 mg

Experimental group

Description:

Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.

Treatment:

Drug: VIB4920

VIB4920 1500 mg

Experimental group

Description:

Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Treatment:

Drug: VIB4920