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
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
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.