AMG0103 in Subjects with Chronic Discogenic Lumber Back Pain

A Phase II, Multicenter, Double-blind, Randomized, Placebo-controlled, Clinical study Evaluating the Efficacy, Safety and Tolerability of a Targeted Single Injection of an Intradiscal AMG0103 in Subjects with Chronic Discogenic Lumber Back Pain

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230145

Enrollment

Registered

2023-06-16

Start date

2023-06-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Discogenic Lumber Back Pain

Interventions

A single targeted injection of AMG0103 (10 mg or 20 mg of cupabimod) or placebo into the disc space.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Patients with chronic low back pain for at least 3 months, where back pain is greater than hip pain and leg pain/ *Patients with low back pain NRS score of at least 4 or more and 9 or less at the screening period and at the Visit 1 (average of two NRS score over a 24 hour period).

Exclusion criteria

Exclusion criteria: *Patients with a history of an endocrine or metabolic bone disorder, rheumatoid arthritis that affects the spine. Undergoing dialysis. *Patients with previous invasive treatments affecting the intervertebral disc.

Design outcomes

Primary

Measure	Time frame
NRS	—

Contacts

Public ContactTadashi Yamada

AnGes Inc.

anges-cr@anges.co.jp+81-357302488

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026