Thyroid Eye DiseasePhase 1/2TEDNCT05683496
Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)
A Phase 1/2 study testing lonigutamab in people with Thyroid Eye Disease, run by ACELYRIN Inc. at 11 sites in 2 countries.
Trial summary
Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- lonigutamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 14 Feb 2023to 26 May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
- Cohort 4 only: Prior history of craniofacial surgery or medical conditions that could alter orbital or facial features.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States6 sites
Clinical Research Site
Ann Arbor, Michigan, 48108
Clinical Research Site
Atlanta, Georgia, 30328
Clinical Research Site
East Setauket, New York, 11733
Clinical Research Site
Jacksonville, Florida, 32216
Clinical Research Site
Morgantown, West Virginia, 26505
Clinical Research Site
New York, New York, 10028
Australia5 sites
Clinical Research Site
Adelaide, South Australia, 5000
Clinical Research Site
East Melbourne, Victoria, 3002
Clinical Research Site
Nedlands, Western Australia, 6009
Clinical Research Site
Sydney, New South Wales, 2109
Clinical Research Site
Woolloongabba, Queensland, 4102
About this study
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)
Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED.
- Conditions
- Thyroid Eye Disease
- Being tested
- lonigutamab, Placebo
- Keywords
- TED
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lonigutamabDrug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21 Receives: Drug: lonigutamab; Drug: Placebo |
| Cohort 2 | Experimental | multiple doses of dose 2 of lonigutamab administered SC injection weekly Receives: Drug: lonigutamab |
| Cohort 3 | Experimental | multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks. Receives: Drug: lonigutamab |
| Cohort 4 | Experimental | multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks. Receives: Drug: lonigutamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Safety and Tolerability
Measured: Day 1 to Day 169
Incidence and characterization of serious treatment emergent adverse events (TEAEs)
Safety and Tolerability
Measured: Day 1 to Day 169
Secondary outcomes (2)
PK profile of lonigutamab
minimum observed concentration (Cmin)
Measured: Day 1 to Day 169
PK profile of lonigutamab
Maximum observed concentration (Cmax)
Measured: Day 1 to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start14 Feb 2023
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Up to 4 cohorts are planned, with each cohort receiving one of 5 different treatment doses
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACELYRIN Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683496
- Sponsor's protocol ID
- 421-01-02
- Acronym
- TED
- Status last verified
- Jun 2025
- First submitted
- 20 Dec 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05683496
- Acronym / sponsor ID
- TED / 421-01-02
- Conditions
- Thyroid Eye Disease
- Keywords
- TED
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- ACELYRIN Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in subjects with TED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Up to 4 cohorts are planned, with each cohort receiving one of 5 different treatment doses
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: lonigutamab, Drug: PlaceboSingle SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21 |
| Cohort 2 | Experimental | Drug: lonigutamabmultiple doses of dose 2 of lonigutamab administered SC injection weekly |
| Cohort 3 | Experimental | Drug: lonigutamabmultiple doses of lonigutamab dose 3 administered SC injection every 4 weeks. |
| Cohort 4 | Experimental | Drug: lonigutamabmultiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lonigutamabsubcutaneous injection | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| Placebosubcutaneous injection | Drug | Cohort 1 |
Primary outcome
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 169
Safety and Tolerability
Incidence and characterization of serious treatment emergent adverse events (TEAEs)
Time frame: Day 1 to Day 169
Safety and Tolerability
2 secondary outcomes
PK profile of lonigutamab
Time frame: Day 1 to Day 169
PK profile of lonigutamab
Time frame: Day 1 to Day 169
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lonigutamab in people with Thyroid Eye Disease, run by ACELYRIN Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs) (time frame: Day 1 to Day 169). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.