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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05524571




Registration number
NCT05524571
Ethics application status
Date submitted
24/08/2022
Date registered
1/09/2022

Titles & IDs
Public title
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
Scientific title
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)
Secondary ID [1] 0 0
IMVT-1401-3202
Universal Trial Number (UTN)
Trial acronym
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 - Batoclimab
Treatment: Drugs - Placebo

Experimental: Batoclimab - Participants will be administered batoclimab 680 mg SC weekly for 12 weeks followed by 340 mg SC weekly for 12 weeks.

Placebo comparator: Placebo - Participants will be administered matching placebo SC weekly for 24 weeks.


Treatment: Drugs: Batoclimab
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

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

Outcomes
Primary outcome [1] 0 0
Percentage of proptosis responders
Timepoint [1] 0 0
At Week 24
Secondary outcome [1] 0 0
Percentage of participants with proptosis =2 mm reduction and Clinical Activity Score (CAS) of less than or equal to (=) 3 from Baseline in the study eye
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Percentage of participants with CAS of 0 or 1 in the study eye
Timepoint [2] 0 0
At Week 24
Secondary outcome [3] 0 0
Mean change from Baseline in CAS in the study eye
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Mean change from Baseline in proptosis in the study eye
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Percentage of participants with =6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Percentage of participants with =8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye
Timepoint [8] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Are =18 years of age at screening.
2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:

* A CAS = 4 in either eye, and
* Clinical evidence of worsened proptosis with:

* Proptosis = 18 mm and/or
* Proptosis = 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
4. Have onset of active TED within 12 months prior to screening.
5. Have documented evidence of detectable anti-TSHR-Ab at screening.
6. Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
7. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.

Additional inclusion criteria are defined in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Have decreased best corrected visual acuity due to optic neuropathy.
2. Have at least a 2-point decrease in CAS or =2 mm decrease in proptosis between screening and Baseline assessments in either eye.
3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to = 1 g of methylprednisolone for the treatment of TED.
5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
6. Had previous orbital irradiation or surgery for TED.

Additional exclusion criteria are defined in the protocol.

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
5/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Number - 7565 - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Belgium
State/province [12] 0 0
Brugge
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Ghent
Country [15] 0 0
Belgium
State/province [15] 0 0
Liège
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Pecs
Country [18] 0 0
Hungary
State/province [18] 0 0
Pécs
Country [19] 0 0
Latvia
State/province [19] 0 0
Ogre
Country [20] 0 0
Latvia
State/province [20] 0 0
Riga
Country [21] 0 0
Latvia
State/province [21] 0 0
Ventspils
Country [22] 0 0
New Zealand
State/province [22] 0 0
Christchurch
Country [23] 0 0
New Zealand
State/province [23] 0 0
Hamilton
Country [24] 0 0
Puerto Rico
State/province [24] 0 0
San Juan
Country [25] 0 0
Slovakia
State/province [25] 0 0
Bratislava
Country [26] 0 0
Slovakia
State/province [26] 0 0
Trencín
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Santiago De Compostela
Country [30] 0 0
Spain
State/province [30] 0 0
Sevilla
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Turkey
State/province [32] 0 0
Adana
Country [33] 0 0
Turkey
State/province [33] 0 0
Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Immunovant Sciences GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Central Study Contact
Address 0 0
Country 0 0
Phone 0 0
18007970414
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05524571