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A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease. (UplighTED)

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ClinicalTrials.gov Identifier: NCT06307626
Recruitment Status : Recruiting
First Posted : March 13, 2024
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
argenx

Tracking Information
First Submitted Date  ICMJE March 6, 2024
First Posted Date  ICMJE March 13, 2024
Last Update Posted Date May 14, 2024
Actual Study Start Date  ICMJE March 28, 2024
Estimated Primary Completion Date February 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2024)		 Percentage of participants who were proptosis responders [ Time Frame: At week 24 of the Double-Blinded Treatment Period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2024)
  • Change in proptosis measurement in the study eye from baseline [ Time Frame: Up to week 24 of the Double-Blinded Treatment Period ]
  • Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline [ Time Frame: Up to week 24 of the Double-Blinded Treatment Period ]
    Minimum value: 0 (most negative impact on Quality of Life); Maximum value: 100 (No impact on Quality of Life)
  • Percentage of participants with a resolution of diplopia (responders) [ Time Frame: At week 24 of the Double-Blinded Treatment Period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2024)
  • Change in proptosis measurement in the study eye from baseline [ Time Frame: Up to week 24 of the Double-Blinded Treatment Period ]
  • Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline [ Time Frame: Up to week 24 of the Double-Blinded Treatment Period ]
  • Percentage of participants with a resolution of diplopia (responders) [ Time Frame: At week 24 of the Double-Blinded Treatment Period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.
Official Title  ICMJE 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
Brief Summary

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.

After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Thyroid Eye Disease
Intervention  ICMJE
  • Combination Product: Efgartigimod PH20 SC
    Subcutaneous efgartigimod PH20 SC given by prefilled syringe
  • Other: Placebo PH20 SC
    Subcutaneous placebo given by prefilled syringe
Study Arms  ICMJE
  • Experimental: Efgartigimod arm
    Participants with active, moderate-to-severe TED receiving Efgartigimod PH20 SC (subcutaneously) via pre-filled syringe (PFS)
    Intervention: Combination Product: Efgartigimod PH20 SC
  • Placebo Comparator: Placebo arm
    Participants with active, moderate-to-severe TED receiving Placebo PH20 SC (subcutaneously) via pre-filled syringe (PFS)
    Intervention: Other: Placebo PH20 SC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2024)		 108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2027
Estimated Primary Completion Date February 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 participant has a physician's diagnosis of 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 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

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sabine Coppieters, MD 857-350-4834 clinicaltrials@argenx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06307626
Other Study ID Numbers  ICMJE ARGX-113-2309
2023-509198-22-00 ( EU Trial (CTIS) Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party argenx
Original Responsible Party Same as current
Current Study Sponsor  ICMJE argenx
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account argenx
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP