Graves' DiseasePhase 3VitaliThyNCT07570316
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
A Phase 3 study testing Efgartigimod PH20 SC in people with Graves' Disease and Graves Disease, run by argenx at 35 sites in 3 countries.
Trial summary
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves' Disease, Graves Disease
- What is being tested?
- Efgartigimod PH20 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 35 sitesin 3 countries
- Study dates
- 10 Jun 2026to May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels >=ULN (upper limit of normal) at screening.
- Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) <0.1 mIU/L at screening.
- Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening.
Who cannot join
- History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter).
- History of RAI (radioactive iodine) therapy or received a total thyroidectomy.
- T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received <6 weeks before screening.
- Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.
- Graves' orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study.
Trial locations and contacts
35 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 3 countries
United States29 sites, 29 recruiting
- Recruiting
Albany Medical College Community Endocrinology
Albany, New York, 12203
Robert Busch, 518 489 4704, thyroiddoc@aol.com
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Tae-Hwa Chun, 734-615-5420, taehwa@med.umich.edu
- Recruiting
Asheville Clinical Research
Asheville, North Carolina, 28803
Lauren Bernstein, +1 857-350-4834, bbernstein@ashevilleclinicaltrials.com
- Recruiting
Profound Research LLC at Tri-City Primary Care
Carlsbad, California, 92012
Jamil Alkhaddo, MD, 419-681-0637, jamil.alkhaddo@profoundresearch.com
- Recruiting
Research Institute of Dallas
Dallas, Texas, 75231
Heidi Shea, MD, 927-867-4658, hshea@eadallas.com
- Recruiting
Metro Detroit Endocrinology Center
Dearborn, Michigan, 48126
Ayman Elkadry, MD, 313-203-5300, aymankad73@gmail.com
- Recruiting
Frontier Medical Center - Academy of Diabetes Thyroid and Endocrine
El Paso, Texas, 79935
Sergio Rovner, 915-633-9387, sergiorovner@hotmail.com
- Recruiting
Profound Research
Farmington Hills, Michigan, 48334
Gary Edelson, MD, 947-254-1920, gary.edelson@profoundresearch.io
- Recruiting
Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location
Fleming Island, Florida, 32003
Senan Sultan, MD, 478-319-7900, drsultan@nerifl.com
- Recruiting
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
Sam Lerman, MD, 954-963-7100, slerman@diabetes-endocare.com
- Recruiting
Juno Research
Houston, Texas, 77040
Damaris Vega, MD, 713-779-5494, Dvega@jcct.com
- Recruiting
Clinic of Endocrinology
Houston, Texas, 77089
Amir Hassan, MD, 281-944-3610, amir@biopharmainfo.net
- Recruiting
Tekton Research Irving
Irving, Texas, 75039
Pablo Mora, MD, 972-566-7799, pablo.mora@tektonresearch.com
- Recruiting
University of Florida Jacksonville College of Medicine
Jacksonville, Florida, 32256
Christian Koch, +1 857-350-4834, Christian.Koch@jax.ufl.edu
- Recruiting
Truman Medical Center
Kansas City, Missouri, 64108
Rajib Bhattacharya, MD, +1 857-350-4834, rajib.bhattacharya@uhkc.org
- Recruiting
Ilumina Medical Research LLC
Kissimmee, Florida, 34744
Max Sosa-Pagan, MD, 857-350-4834, MSosapaganMD@gmail.com
- Recruiting
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, 66219
Thomas Kreamer, MD, 913-825-4400, tkreamer@jcct.com
- Recruiting
Biopharma Informatic, LLC
McAllen, Texas, 78503
Gloria Ortiz, MD, 281-944-3610, gortiz@biopharmainfo.net
- Recruiting
Tekton Research - McKinney
McKinney, Texas, 75069
Muhammad Siddiqui, MD, 972-777-6011, muhammad.siddiqui@tektonresearch.com
- Recruiting
Southern Endocrinology Associates PA
Mesquite, Texas, 75149
Sumana Gangi, MD, 214-909-8904, sumana_gangi@yahoo.com
- Recruiting
Oceane 7 Medical & Research Center, Inc
Miami, Florida, 33144
Orlando Fernandez, 305 261 2738, o.fernandez.oceane7@gmail.com
- Recruiting
Endocrine Associates of West Village PC
New York, New York, 10016
Anastasios Manessis, MD, 646-660-9991, amanessis@endocrinenyc.com
- Recruiting
Diabetes Associates Medical Group
Orange, California, 92868
Ivy-Joan Madu, MD, 714-202-8894, diabetesmd@sbcglobal.net
- Recruiting
Pasadena Clinical Trials
Pasadena, California, 91101
Tzu-Jen Tzao, 5206127860, ttzao@pasadenatrials.com
- Recruiting
Havana Research Institute LLC.
Pasadena, California, 91105
John De Beixedon, MD, 626-698-9794, drjohn@havanaresearchinstitute.com
- Recruiting
Wake Internal Medicine Consultants
Raleigh, North Carolina, 27612
Juman Takeddin, MD, 919-781-7500, jtakeddin@wakeinternalmedicine.com
- Recruiting
San Jose Clinical Trials
San Jose, California, 95128
Richard Cherlin, 408-358-2663, rcherlin@sanjosetrials.com
- Recruiting
Consano Clinical Research
Shavano Park, Texas, 78231
Daniel Katselnik, MD, 210-545-4900, katselnik.md@consanosa.com
- Recruiting
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67226
Terry Klein, 316-689-6629, terry.klein@amr-clinical.com
Georgia5 sites, 5 recruiting
- Recruiting
LLC American Hospital Network
Tbilisi, 0102
Nino Gabidzashvili, MD, endo.advice@gmail.com
- Recruiting
LTD Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, 0112
Miranda Baratashvili, MD, baratashvilimiranda@gmail.com
- Recruiting
New Hospitals
Tbilisi, 0114
Lia Katcharava, MD, +995 599530278, likakatcharava@yahoo.com
- Recruiting
LLC Todua Clinic
Tbilisi, 0119
Tamar Khutsishvili, MD, Khutsishvilitamar1@outlook.com
- Recruiting
In Vitro Fertilization Center LLC
Tbilisi, 0159
Tea Khurodze, MD, khurodze@yahoo.com
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth Hospital (Gateshead Health NHS Foundation Trust)
Gateshead, Tyne and Wear, NE9 6SX
Syed Salman Razvi, +44 191 445 6052, salman.razvi@newcastle.ac.uk
About this study
Official title: A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.
The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment.
Read more
The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment.
More information can be found here: https://clinicaltrials.argenx.com/vitalithy
- Conditions
- Graves' Disease, Graves Disease
- Being tested
- Efgartigimod PH20 SC, Placebo PH20 SC
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SCBiological
Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Placebo PH20 SCOther
Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| Part A - efgartigimod PH20 SC PFS | Experimental | Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. Receives: Biological: Efgartigimod PH20 SC |
| Part A - placebo PH20 SC PFS | Placebo comparator | Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. Receives: Other: Placebo PH20 SC |
| Part B - efgartigimod PH20 SC PFS | Experimental | Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. Receives: Biological: Efgartigimod PH20 SC |
| Part B - placebo PH20 SC PFS | Experimental | Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. Receives: Other: Placebo PH20 SC |
| Part C - efgartigimod PH20 SC PFS | Experimental | Participants will receive efgartigimod PH20 SC PFS in the part C open-label treatment period Receives: Biological: Efgartigimod PH20 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
Free triiodothyronine: [fT3]; free thyroxine: [fT4]; ATDs: antithyroid drugs
Measured: Up to 24 weeks (part A)
Secondary outcomes (20)
Time to becoming euthyroid off ATDs in part A
ATDs: antithyroid drugs
Measured: Up to 24 weeks (part A)
Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day at week 24 in part A
MMI: methimazole (also known as thiamazole); CBZ: carbimazole.
Measured: Up to 24 weeks (part A)
Percentage of participants with fT3 and fT4 levels below the ULN off ATDs at week 24 in part A
ULN : upper limit of normal; ATDs: antithyroid drugs.
Measured: Up to 24 weeks (part A)
Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A
TRAb: anti-TSHR autoantibodies; ATDs: antithyroid drugs.
Measured: Up to 24 weeks (part A)
Time to becoming euthyroid off ATDs and TRAb seronegative
ATDs: antithyroid drugs; TRAb: anti-TSHR autoantibodies.
Measured: Up to 24 weeks (part A) + up to 135 weeks
Time to becoming euthyroid and receiving an ATD dose of MMI ≤5 mg/day or CBZ ≤7.5 mg/day (part A)
ATDs: antithyroid drugs; MMI: methimazole (also known as thiamazole); CBZ: carbimazole.
Measured: Up to 24 weeks (Part A)
Time to becoming euthyroid
Measured: Up to 24 weeks (part A) + up to 135 weeks
Time to having TSH within normal ranges among participants who have TSH lower than the LLN at baseline (part A)
TSH: thyroid-stimulating hormone; LLN: lower limit of normal.
Measured: Up to 24 weeks (part A)
Percentage of participants who remain euthyroid without ATDs
ATDs: antithyroid drug
Measured: Up to 74 weeks (part B)
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months
ATDs: antithyroid drug
Measured: Up to 74 weeks (part B) + up to 135 weeks
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS
ATDs: antithyroid drug
Measured: Up to 72 weeks (part C)
Incidence of AEs and SAEs
AEs: adverse events ; SAEs: serious adverse events.
Measured: Up to 135 weeks
Change in ThyPRO-39 over time
The Thyroid-Specific Patient-Reported Outcome Short Form (ThyPRO-39) 39 item version of the ThyPRO. Each item is related to a specific aspect of the participant's experience with their thyroid condition. Each item is scored on a 5-point Likert scale, and the scores are then transformed to a 0-to-100 scale. Higher scores indicate worse health status.
Measured: Up to 135 weeks
Change in PROMIS-PF10a over time
The Patient-Reported Outcomes Measurement Information System Physical Function-10 item (PROMIS-PF10a) is a self-administered physical functioning assessment comprising 10 items that measure respondents' ability to perform common physical tasks. Scoring involves summing the numerical responses to each item; higher scores indicate better physical function.
Measured: Up to 135 weeks
Efgartigimod serum concentrations over time
Measured: Up to 24 weeks (part A) + 72 weeks (part C)
Percentage change from baseline in total IgG levels in serum over time
IgG: immunoglobulin G
Measured: Up to 98 weeks
Percentage change from baseline in TRAb serum levels over time
TRAb: anti-TSHR autoantibodies.
Measured: Up to 135 weeks
Incidence of ADA against efgartigimod in serum
ADA: antidrug antibody(ies)
Measured: Up to 24 weeks (part A) + up to 135 weeks
Incidence of antibodies against rHuPH20 in plasma
rHuPH20: recombinant human hyaluronidase PH20
Measured: Up to 24 weeks (part A) + Up to 135 weeks
Incidence of NAb against efgartigimod in serum and rHuPH20 in plasma
NAb: neutralizing antibody(ies); rHuPH20: recombinant human hyaluronidase PH20.
Measured: Up to 24 weeks (part A) + up to 135 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570316
- Sponsor's protocol ID
- ARGX-113-25-GRD-3002
- Other IDs
- 2025-524223-42-00, 2025
- Acronym
- VitaliThy
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs
- ClinicalTrials.gov ID
- NCT07570316
- Acronym / sponsor ID
- VitaliThy / ARGX-113-25-GRD-3002
- Conditions
- Graves' Disease, Graves Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 6 May 2026 (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.
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.
The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment.
The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment.
More information can be found here: https://clinicaltrials.argenx.com/vitalithy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A - efgartigimod PH20 SC PFS | Experimental | Biological: Efgartigimod PH20 SCParticipants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. |
| Part A - placebo PH20 SC PFS | Placebo comparator | Other: Placebo PH20 SCParticipants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. |
| Part B - efgartigimod PH20 SC PFS | Experimental | Biological: Efgartigimod PH20 SCParticipants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. |
| Part B - placebo PH20 SC PFS | Experimental | Other: Placebo PH20 SCParticipants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. |
| Part C - efgartigimod PH20 SC PFS | Experimental | Biological: Efgartigimod PH20 SCParticipants will receive efgartigimod PH20 SC PFS in the part C open-label treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels >=ULN (upper limit of normal) at screening.
- Has active hyperthyroidism due to GD with TSH (thyroid-stimulating hormone) <0.1 mIU/L at screening.
- Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening.
Key exclusion criteria (5 listed)
- History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter).
- History of RAI (radioactive iodine) therapy or received a total thyroidectomy.
- T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements) received <6 weeks before screening.
- Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or tachyarrhythmia related to GD, such as atrial fibrillation or atrial flutter not sufficiently controlled with medications.
- Graves' orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital radiation, or expected immediate surgical intervention and/or planned corrective surgery/irradiation or medical therapy during the study.
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 |
|---|---|---|
| Efgartigimod PH20 SCSubcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS) | Biological | Part A - efgartigimod PH20 SC PFS, Part B - efgartigimod PH20 SC PFS, Part C - efgartigimod PH20 SC PFS |
| Placebo PH20 SCSubcutaneous injection of placebo PH20 via Prefilled Syringe (PFS) | Other | Part A - placebo PH20 SC PFS, Part B - placebo PH20 SC PFS |
Primary outcome
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A
Time frame: Up to 24 weeks (part A)
Free triiodothyronine: [fT3]; free thyroxine: [fT4]; ATDs: antithyroid drugs
20 secondary outcomes
Time to becoming euthyroid off ATDs in part A
Time frame: Up to 24 weeks (part A)
Percentage of participants who are euthyroid and receiving MMI ≤5 mg/day or CBZ ≤7.5 mg/day at week 24 in part A
Time frame: Up to 24 weeks (part A)
Percentage of participants with fT3 and fT4 levels below the ULN off ATDs at week 24 in part A
Time frame: Up to 24 weeks (part A)
Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A
Time frame: Up to 24 weeks (part A)
Time to becoming euthyroid off ATDs and TRAb seronegative
Time frame: Up to 24 weeks (part A) + up to 135 weeks
Time to becoming euthyroid and receiving an ATD dose of MMI ≤5 mg/day or CBZ ≤7.5 mg/day (part A)
Time frame: Up to 24 weeks (Part A)
Time to becoming euthyroid
Time frame: Up to 24 weeks (part A) + up to 135 weeks
Time to having TSH within normal ranges among participants who have TSH lower than the LLN at baseline (part A)
Time frame: Up to 24 weeks (part A)
Percentage of participants who remain euthyroid without ATDs
Time frame: Up to 74 weeks (part B)
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS for 6, 12, and 18 months
Time frame: Up to 74 weeks (part B) + up to 135 weeks
Percentage of participants who remain euthyroid without ATDs and without efgartigimod PH20 SC PFS
Time frame: Up to 72 weeks (part C)
Incidence of AEs and SAEs
Time frame: Up to 135 weeks
Change in ThyPRO-39 over time
Time frame: Up to 135 weeks
Change in PROMIS-PF10a over time
Time frame: Up to 135 weeks
Efgartigimod serum concentrations over time
Time frame: Up to 24 weeks (part A) + 72 weeks (part C)
Percentage change from baseline in total IgG levels in serum over time
Time frame: Up to 98 weeks
Percentage change from baseline in TRAb serum levels over time
Time frame: Up to 135 weeks
Incidence of ADA against efgartigimod in serum
Time frame: Up to 24 weeks (part A) + up to 135 weeks
Incidence of antibodies against rHuPH20 in plasma
Time frame: Up to 24 weeks (part A) + Up to 135 weeks
Incidence of NAb against efgartigimod in serum and rHuPH20 in plasma
Time frame: Up to 24 weeks (part A) + up to 135 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Study websiteLink provided by the sponsor.
- 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.
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efgartigimod PH20 SC in people with Graves' Disease and Graves Disease, run by argenx at 35 sites in 3 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Georgia, United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who are euthyroid (fT3, fT4, and TSH within normal ranges) off ATDs at week 24 in part A (time frame: Up to 24 weeks (part A)). 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 3 Nov 2026.