臨床研究等提出・公開システム

A PHASE III, RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PARTICIPANTS WITH MODERATE-TO-SEVERE THYROID EYE DISEASE

A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease

Giulio Barteselli

F. Hoffmann-La Roche Ltd

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Nov. 30, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Clinical diagnosis of thyroid eye disease (TED) based on CAS

-Decrease in CAS or proptosis of >= 2 points or >= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)
-Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator
-Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study
-Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
-Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab

Both

thyroid eye disease(TED)

Satralizumab: SC injection at protocol-specified doses every 4 weeks (Q4W)

efficacy
To evaluate the efficacy of satralizumab compared with placebo
-Percentage of participants achieving >= 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
(Provided there is no deterioration of proptosis (>= 2mm increase) in the fellow eye)

safety, efficacy, phamacokinetics, phamacodynamics, other
To evaluate the efficacy of satralizumab compared with placebo
-Change in proptosis from baseline to Week 24
-Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia

To evaluate the safety of satralizumab compared with placebo
-Percentage of participants with adverse events (AEs), with severity determined according to National cancer institute common terminology criteria for adverse events version 5 (NCI CTCAE V5)

+81-11-706-7061

Aug. 15, 2023

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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