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Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)

Sponsored by ACELYRIN Inc.

About this trial

Last updated 2 years ago

Study ID

421-01-02

Status

Recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED.

What are the Participation Requirements?

Key Inclusion Criteria:

- Male or female, ≥18 and ≤70 years of age.

- Proptosis defined in the study eye as ≥3 mm above normal.

- Clinical Activity Score (CAS) ≥4 (using a 7-item scale) for the most severely affected
eye

- Onset of active TED symptoms within 15 months prior to the baseline

- Must agree to use highly effective contraception as specified in the protocol

Key Exclusion Criteria:

- Pathology related to inflammatory bowel disease or irritable bowel syndrome.

- Clinically significant pathology related to hearing or history of hearing impairment

- Optic neuropathy

- Corneal decompensation unresponsive to medical management.

- Previous orbital irradiation (for any cause) or any previous surgical treatment for
TED.

- Subjects with diabetes or hemoglobin A1c >6.0% at screening

- Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to >3 g
of methylprednisolone for the treatment of TED within the last year.

- Previous steroid use (IV or oral) specifically for the treatment of TED not to exceed
1 g total dose in the 8 weeks prior to Screening.

- Previous use of teprotumumab or any other IGF-1 receptor (IGF-1R) inhibitor.

- Any previous treatment with a biologic drug for the treatment of TED (eg, rituximab
and tocilizumab)

- Any other immunosuppressive agent within 1 month of screening.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting