Clinical trial NCT05683496: Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)
Official title: A Phase 1/2, Adaptive, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Clinical Efficacy of Lonigutamab in Subjects With Thyroid Eye Disease (TED)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Thyroid Eye Disease
Keywords: TED
Lead sponsor: ACELYRIN Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Up to 4 cohorts are planned, with each cohort receiving one of 5 different treatment doses
Primary purpose: TREATMENT

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


Eligibility criteria: Key Inclusion Criteria:

* Male or female, ≥18 and ≤75 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 prior to 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 \&gt;6.0% at screening
* Any steroid use (intravenous \[IV\] or oral) with a cumulative dose equivalent to \&gt;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.
* Cohort 4 only: Prior history of craniofacial surgery or medical conditions that could alter orbital or facial features.

Primary outcomes:
measure: Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
timeFrame: Day 1 to Day 169
measure: Incidence and characterization of serious treatment emergent adverse events (TEAEs)
timeFrame: Day 1 to Day 169
Secondary outcomes:
measure: PK profile of lonigutamab
timeFrame: Day 1 to Day 169
measure: PK profile of lonigutamab
timeFrame: Day 1 to Day 169
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Clinical Research Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Ann Arbor
country: United States
facility: Clinical Research Site
state: Michigan
city: East Setauket
country: United States
facility: Clinical Research Site
state: New York
city: New York City
country: United States
facility: Clinical Research Site
state: New York
city: Morgantown
country: United States
facility: Clinical Research Site
state: West Virginia
city: Sydney
country: Australia
facility: Clinical Research Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Clinical Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Clinical Research Site
state: South Australia
city: East Melbourne
country: Australia
facility: Clinical Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Clinical Research Site
state: Western Australia
Study officials:
References: