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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06307613




Registration number
NCT06307613
Ethics application status
Date submitted
6/03/2024
Date registered
13/03/2024

Titles & IDs
Public title
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults with Thyroid Eye Disease
Scientific title
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants with Thyroid Eye Disease
Secondary ID [1] 0 0
2023-509197-35-00
Secondary ID [2] 0 0
ARGX-113-2301
Universal Trial Number (UTN)
Trial acronym
UplighTED
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
Other interventions - Efgartigimod PH20 SC
Other interventions - Placebo PH20 SC

Experimental: Efgartigimod arm - Participants with active, moderate-to-severe TED receiving Efgartigimod PH20 SC (subcutaneously) via pre-filled syringe (PFS)

Placebo comparator: Placebo arm - Participants with active, moderate-to-severe TED receiving Placebo PH20 SC (subcutaneously) via pre-filled syringe (PFS)


Other interventions: Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Other interventions: Placebo PH20 SC
Subcutaneous placebo given by prefilled syringe
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants who were proptosis responders
Timepoint [1] 0 0
At week 24 of the Double-Blinded Treatment Period
Secondary outcome [1] 0 0
Change in proptosis measurement in the study eye from baseline
Timepoint [1] 0 0
Up to week 24 of the Double-Blinded Treatment Period
Secondary outcome [2] 0 0
Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline
Timepoint [2] 0 0
Up to week 24 of the Double-Blinded Treatment Period
Secondary outcome [3] 0 0
Percentage of participants with a resolution of diplopia (responders)
Timepoint [3] 0 0
At week 24 of the Double-Blinded Treatment Period

Eligibility
Key inclusion criteria
* The participant is at least 18 years of age
* The participant is capable of providing signed informed consent and following with protocol requirements
* The investigator determines active, moderate-to-severe thyroid eye disease (TED) associated with autoimmune thyroid conditions (Graves' disease or Hashimoto's thyroiditis) for the most severely affected eye
* The participant has first onset of active TED symptoms within 12 months before screening
* The participant must have normal thyroid function with the baseline disease under control or have mild hypo or hyperthyroidism at screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the normal thyroid function for the full duration of the study
* The participant agrees to use birth control consistent with local regulations and the people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Optic neuropathy (damage to optic nerve), defined as new visual field defect (blind spot), relative afferent pupillary defect (pupils respond differently to light), or color defect secondary to optic nerve involvement within the 6 months before screening
* Corneal decompensation (swelling of the cornea) unresponsive to medical management
* Previous orbital irradiation or surgery for TED
* Use of some medications before screening (more information is found in the protocol)
* Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of TED or puts the participant at undue risk
* History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for =3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer
* Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV
* Current participation in another interventional clinical study or previous participation in an efgartigimod clinical study and at least 1 dose of study drug received or has received at least 1 dose of commercially available efgartigimod
* Known hypersensitivity to study drug or one of its excipients (inactive ingredients)
* History of or current alcohol, drug, or medication abuse within 12 months before screening as assessed by the investigator
* Pregnant or lactating state or intention to become pregnant during the study
* Live or live-attenuated vaccine received <4 weeks before screening

The complete list of exclusion criteria can be found 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 administering 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
27/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - Melbourne
Recruitment hospital [2] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [3] 0 0
Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 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
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Stara Zagora
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Varna
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Foshan
Country [12] 0 0
China
State/province [12] 0 0
Fuzhou
Country [13] 0 0
China
State/province [13] 0 0
Hangzhou
Country [14] 0 0
China
State/province [14] 0 0
Hefei
Country [15] 0 0
China
State/province [15] 0 0
Luoyang
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Shenyang
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Pardubice
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Praha
Country [20] 0 0
Estonia
State/province [20] 0 0
Parnu
Country [21] 0 0
Estonia
State/province [21] 0 0
Tartu
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Greece
State/province [23] 0 0
Athens
Country [24] 0 0
Greece
State/province [24] 0 0
Patras
Country [25] 0 0
Greece
State/province [25] 0 0
Thessaloniki
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Hungary
State/province [27] 0 0
Pecs
Country [28] 0 0
Italy
State/province [28] 0 0
Firenze
Country [29] 0 0
Italy
State/province [29] 0 0
Genova
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Naples
Country [32] 0 0
Italy
State/province [32] 0 0
Varese
Country [33] 0 0
Romania
State/province [33] 0 0
Bucuresti
Country [34] 0 0
Romania
State/province [34] 0 0
Iasi
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Majadahonda
Country [38] 0 0
Spain
State/province [38] 0 0
Santiago de Compostela
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Frimley
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
argenx
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
Sabine Coppieters, MD
Address 0 0
Country 0 0
Phone 0 0
857-350-4834
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06307613