A trial to investigate the efficacy, safety and tolerability of an intravenous infusion of HZN-001 compared with placebo in treating male and female Japanese participants at least 18 years of age with chronic (inactive) thyroid eye disease

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Approximately 66 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 2:1 ratio (stratified by tobacco use status and presence of diplopia at Baseline) to receive 8 infusions of HZN‐001 (10 mg/kg for the first infusion and 20 mg/kg for the remaining 7 infusions) or placebo once every 3 weeks (q3W). All participants will enter a 24‐week Double‐masked Treatment Period, during which IP will be infused on Day 1 (Baseline) and Weeks 3, 6, 9, 12, 15, 18 and 21 (with a final visit at Week 24 of the 24‐week Treatment Period). CONDITION: Chronic (Inactive) Thyroid Eye Disease PRIMARY OUTCOME: Proptosis responder rate (defined as the percentage of participants with a >= 2‐mm reduction from Baseline in proptosis in the study eye without deterioration of proptosis [increase >= 2 mm] in the fellow eye) at Week 24 INCLUSION CRITERIA: 1. Participant has provided written informed consent. 2. Participant is male or female at least 18 years old at Screening. 3. Participant has an initial diagnosis of TED >= 2 years but < 10 years prior to Screening. Clinical diagnosis of stable cTED, as determined by participant medical records indicating a CAS <= 2 in both eyes for at least 1 year prior to Screening, or all of the following: a. No progression in proptosis for at least 1 year prior to Screening b. If participant has history of diplopia due to TED, no progression in diplopia for at least 1 year prior to Screening c. No new inflammatory TED symptoms for at least 1 year prior to Screening. 4. Participant has CAS <= 2 at the Screening and Baseline Visits. 5. Participant has proptosis >=3‐mm increase from the participant's baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis >= 18 mm. 6. Participants must be euthyroid with the participant's ba
Epistemonikos ID: 635144babaea1a1f84067140847740fb6732cbfd
First added on: Aug 26, 2024