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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05683496




Registration number
NCT05683496
Ethics application status
Date submitted
20/12/2022
Date registered
13/01/2023
Date last updated
22/03/2024

Titles & IDs
Public title
Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED)
Scientific 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)
Secondary ID [1] 0 0
421-01-02
Universal Trial Number (UTN)
Trial acronym
TED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Eye Disease 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lonigutamab
Treatment: Drugs - Placebo

Experimental: Cohort 1 - Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21

Experimental: Cohort 2 - multiple doses of dose 2 of lonigutamab administered SC injection weekly

Experimental: Cohort 3 - multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.


Treatment: Drugs: lonigutamab
subcutaneous injection

Treatment: Drugs: Placebo
subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
Day 1 to Day 169
Primary outcome [2] 0 0
Incidence and characterization of serious treatment emergent adverse events (TEAEs)
Timepoint [2] 0 0
Day 1 to Day 169
Secondary outcome [1] 0 0
PK profile of lonigutamab
Timepoint [1] 0 0
Day 1 to Day 169
Secondary outcome [2] 0 0
PK profile of lonigutamab
Timepoint [2] 0 0
Day 1 to Day 169

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Clinical Research Site - Sydney
Recruitment hospital [2] 0 0
Clinical Research Site - Woolloongabba
Recruitment hospital [3] 0 0
Clinical Research Site - Adelaide
Recruitment hospital [4] 0 0
Clinical Research Site - East Melbourne
Recruitment hospital [5] 0 0
Clinical Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2109 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
West Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ACELYRIN Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase 1/2, multicenter, multiple dose clinical study designed to evaluate lonigutamab in
subjects with TED.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05683496
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Helliner Santulli, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
805-456-4393
Fax 0 0
Email 0 0
clinicaltrials@acelyrin.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05683496