A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Purpose
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
Conditions
- Graves' Disease
- Graves Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A - efgartigimod PH20 SC PFS |
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. |
|
|
Placebo Comparator Part A - placebo PH20 SC PFS |
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part A double-blinded treatment period. |
|
|
Experimental Part B - efgartigimod PH20 SC PFS |
Participants will receive efgartigimod PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. |
|
|
Experimental Part B - placebo PH20 SC PFS |
Participants will receive placebo PH20 SC Via Prefilled Syringe (PFS) during the part B treatment period. |
|
|
Experimental Part C - efgartigimod PH20 SC PFS |
Participants will receive efgartigimod PH20 SC PFS in the part C open-label treatment period |
|
Recruiting Locations
Diabetes Associates Medical Group
Orange, California 92868
Orange, California 92868
Havana Research Institute LLC.
Pasadena, California 91105
Pasadena, California 91105
Northeast Florida Endocrine & Diabetes Associates (NEFEDA) - Orange Park Location
Fleming Island, Florida 32003
Fleming Island, Florida 32003
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida 33312
Fort Lauderdale, Florida 33312
Ilumina Medical Research LLC
Kissimmee, Florida 34744
Kissimmee, Florida 34744
Johnson County Clin-Trials, Inc.
Lenexa, Kansas 66219
Lenexa, Kansas 66219
Metro Detroit Endocrinology Center
Dearborn, Michigan 48126
Dearborn, Michigan 48126
Profound Research
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Endocrine Associates of West Village PC
New York, New York 10016
New York, New York 10016
Research Institute of Dallas
Dallas, Texas 75231
Dallas, Texas 75231
Tekton Research Irving
Irving, Texas 75039
Irving, Texas 75039
Biopharma Informatic, LLC
McAllen, Texas 78503
McAllen, Texas 78503
Tekton Research - McKinney
McKinney, Texas 75069
McKinney, Texas 75069
Southern Endocrinology Associates PA
Mesquite, Texas 75149
Mesquite, Texas 75149
Consano Clinical Research
Shavano Park, Texas 78231
Shavano Park, Texas 78231
More Details
- Status
- Recruiting
- Sponsor
- argenx