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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523333-26-00 | EU Trial (CTIS) Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Part B - efgartigimod PH20 SC PFS | Experimental | Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. |
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| Part B - placebo PH20 SC PFS | Experimental | Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. |
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| Part C - efgartigimod PH20 SC PFS | Experimental | Participants, will receive efgartigimod PH20 SC PFS in the part C open-label treatment period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efgartigimod PH20 SC | Biological | Subcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 24 weeks (part A) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to becoming euthyroid off ATDs in part A | ATDs: antithyroid drugs | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | clinicaltrials@argenx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| High Technology Hospital Medcenter LLC | Recruiting | Batumi | 6000 | Georgia |
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| Label | URL |
|---|---|
| Study website | View source |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| Placebo PH20 SC | Other | Subcutaneous injection of placebo PH20 via Prefilled Syringe (PFS) |
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MMI: methimazole (also known as thiamazole); CBZ carbimazole
| 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 | 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 | up to 24 weeks (part A) |
| Time to becoming euthyroid off ATDs and TRAb seronegative | ATDs: antithyroid drugs; TRAb: anti-TSHR autoantibodies | 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 | up to 24 weeks |
| Time to becoming euthyroid | up to 24 weeks (part A) + up to 135 weeks |
| Time to having fT3 and fT4 levels within normal ranges among participants who had fT3 and/or fT4 more than the ULN at baseline (part A) | ULN : upper limit of normal | up to 24 weeks (part A) |
| 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 | up to 24 weeks (part A) |
| Percentage of participants who remain euthyroid without ATDs | ATDs: antithyroid drug | 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 | 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 | up to 72 weeks (part C) |
| Incidence of AEs and SAEs | AEs: adverse events ; SAEs: serious adverse events | 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 | 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. | up to 135 weeks |
| Efgartigimod serum concentrations over time | 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 | up to 98 weeks |
| Percentage change from baseline in TRAb serum levels over time | TRAb: anti-TSHR autoantibodies | up to 135 weeks |
| Incidence of ADA against efgartigimod in serum | ADA: antidrug antibody(ies) | up to 24 weeks (part A) + up to 135 weeks |
| Incidence of antibodies against rHuPH20 in plasma | rHuPH20: recombinant human hyaluronidase PH20 | 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 | up to 24 weeks (part A) + up to 135 weeks |
| First Medical Clinic Ltd | Recruiting | Tbilisi | 0102 | Georgia |
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| LTD MediClub Georgia | Recruiting | Tbilisi | 0160 | Georgia |
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| Aso Iizuka Hospital | Recruiting | Iizuka | 820-8505 | Japan |
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| National Hospital Organization Kyoto Medical Center | Recruiting | Kyoto | 612-0861 | Japan |
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| SHOWA Medical University Northern Yokohama Hospital | Recruiting | Yokohama | 224-8503 | Japan |
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| Tottori University Hospital | Recruiting | Yonago | 683-8504 | Japan |
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| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |