A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
ConditionGraves Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
Sponsorargenx
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
efgartigimod PH20 SC
Biological/VaccineSubcutaneous injection of Efgartigimod PH20 Via Prefilled Syringe (PFS)
Placebo PH20 SC
Other interventionSubcutaneous injection of placebo PH20 via Prefilled Syringe (PFS)
Treatment groups
230 Participants
are divided into 5 treatment groupsGroup A: Part A - efgartigimod PH20 SC PFSExperimental treatment 1 intervention
Group B: Part A - placebo PH20 SC PFSPlacebo comparator 1 intervention
Group C: Part B - efgartigimod PH20 SC PFSExperimental treatment 1 intervention
Group D: Part B - placebo PH20 SC PFSExperimental treatment 1 intervention
Group E: Part C - efgartigimod PH20 SC PFSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
up to 24 weeks (part A)Secondary outcomes
1
Time to becoming euthyroid off ATDs in part A
ATDs: antithyroid drugs
Time frame
Up to 24 weeks (part A)2
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
Time frame
up to 24 weeks (part A)3
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
Time frame
Up to 24 weeks (part A)4
Percentage of participants who are euthyroid off ATDs and TRAb seronegative at week 24 in part A
TRAb: anti-TSHR autoantibodies; ATDs: antithyroid drugs
Time frame
up to 24 weeks (part A) Source ClinicalTrials.gov