NCT05683496 (TED) is a Phase 1, PHASE2 clinical trial of lonigutamab in Thyroid Eye Disease, sponsored by ACELYRIN Inc..

Who is sponsoring NCT05683496?

NCT05683496 is sponsored by ACELYRIN Inc..

What drugs are being tested in NCT05683496?

Interventions in NCT05683496: lonigutamab, Placebo.

What condition does NCT05683496 study?

NCT05683496 studies Thyroid Eye Disease.

Is NCT05683496 still recruiting?

NCT05683496 is currently completed. Last updated 1 July 2025.

Last reviewed 2025-07-01 · How we verify

NCT05683496: TED

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Last updated 1 July 2025

What this trial tests

Phase 1, PHASE2 trial testing lonigutamab in Thyroid Eye Disease in 31 participants. Completed in 26 May 2025.

Timeline

14 February 2023

Primary endpoint
26 May 2025

26 May 2025

Quick facts

Lead sponsor	ACELYRIN Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	31
Start date	14 February 2023
Primary completion	26 May 2025
Estimated completion	26 May 2025
Sites	11 locations across United States, Australia

Drugs / interventions tested

lonigutamab — full drug profile →
Placebo

Conditions studied

Thyroid Eye Disease — all drugs for Thyroid Eye Disease →

Sponsor

ACELYRIN Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Thyroid Eye Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

A Comprehensive Review of Thyroid Eye Disease Pathogenesis: From Immune Dysregulations to Novel Diagnostic and Therapeutic Approaches.
Kulbay M, Tanya SM, Tuli N, Dahoud J, et al · · 2024 · cited 18× · PMID 39519180 · DOI 10.3390/ijms252111628
Thyroid Eye Disease: Advancements in Orbital and Ocular Pathology Management.
Scarabosio A, Surico PL, Singh RB, Tereshenko V, et al · · 2024 · cited 17× · PMID 39064030 · DOI 10.3390/jpm14070776
Emerging therapies in the medical management of thyroid eye disease.
Kamboj A, Harrison AR, Mokhtarzadeh A. · · 2023 · cited 4× · PMID 38983101 · DOI 10.3389/fopht.2023.1295902
Can chimeric antigen receptors - based therapy bring a gleam of hope for thyroid-associated ophthalmopathy and other autoimmune diseases?
Zhou W, Zhu X, Shi Y. · · 2025 · PMID 40838106 · DOI 10.1515/mr-2024-0099
12318 Preliminary Safety and Efficacy of Subcutaneous Lonigutamab (anti-IGF-1R) from a Phase 1/2 Proof of Concept Study in Patients with Thyroid Eye Disease
· 2024

Verify or expand the search:

Other recruiting trials for Thyroid Eye Disease

Currently open trials in the same condition.

NCT07423013 — Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease. · NA · recruiting
NCT07113262 — A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease · Phase 3 · recruiting
NCT06557850 — A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease · Phase 1 · active not recruiting
NCT06625411 — An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED) · Phase 3 · active not recruiting
NCT06625398 — An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) · Phase 3 · active not recruiting

Other ACELYRIN Inc. trials

Trials by the same sponsor.

NCT05905783 — Hidradenitis Suppurativa Study of Izokibep · Phase 3 · terminated
NCT05623345 — Psoriatic Arthritis Study of Izokibep · Phase 2, PHASE3 · terminated
NCT05384249 — Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis · Phase 2 · terminated
NCT05355805 — Hidradenitis Suppurativa Phase 2b Study of Izokibep · Phase 2 · completed
NCT04706741 — A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05683496 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ACELYRIN Inc.
Last refreshed: 1 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05683496.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing