Trial · NCT05524571
Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
NCT05524571, Phase 3, Completed, Immunovant Sciences GmbH
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease. Trials, record NCT05524571. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05524571
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease
- NCT number
- NCT05524571
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 86 participants, actual
- Lead sponsor
- Immunovant Sciences GmbH
- Conditions
- Thyroid Eye Disease
- Interventions
- Batoclimab, Placebo
- First posted
- 2022-09-01
- Last updated
- 2026-04-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of proptosis responders | At Week 24 | Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements are recorded using the Hertel exophthalmometer. The study eye is defined as the most severely affected eye at the Baseline visit. Proptosis responder is defined as the participant with a greater than or equal to (≥) 2 millimeters (mm) reduction in the study eye without deterioration (≥2 mm increase) in the fellow eye. |
| Secondary | Percentage of participants with proptosis ≥2 mm reduction and Clinical Activity Score (CAS) of less than or equal to (≤) 3 from Baseline in the study eye | Baseline and Week 24 | The CAS measures the classical signs of acute inflammation (pain, redness, and swelling) in TED. The 7-item scale assigns 1 point for the presence of each of the parameters assessed: spontaneous retrobulbar pain, pain on attempted upward or downward gaze, redness of eyelids, redness of conjunctiva, swelling of caruncle or plica, swelling of eyelids, swelling of conjunctiva (chemosis). The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity. Higher scores indicate worse symptoms. |
| Secondary | Percentage of participants with CAS of 0 or 1 in the study eye | At Week 24 | |
| Secondary | Mean change from Baseline in CAS in the study eye | Baseline and Week 24 | |
| Secondary | Percentage of participants with positive binding anti-thyroid stimulating hormone receptor (TSHR) antibody (Ab) at Baseline who achieve seroconversion | Baseline and Week 24 | |
| Secondary | Percentage of participants with decrease of at least 1 grade from Baseline in Gorman score for diplopia | Baseline and Week 24 | Diplopia will be assessed based on 3 grades: Grade I - Intermittent diplopia (diplopia in primary position of gaze, when tired or when first awakening), Grade II - Inconstant diplopia (diplopia at extremes of gaze) and Grade III - Constant diplopia (continuous diplopia in primary or reading position). Higher scores indicate worse symptoms. |
| Secondary | Mean change from Baseline in proptosis in the study eye | Baseline and Week 24 | |
| Secondary | Percentage of participants with ≥6-point increase from Baseline in total Graves' ophthalmopathy - Quality of life (GO-QOL) score | Baseline and Week 24 | The GO-QOL is a 16-item self-administered questionnaire designed to assess how GO affects different aspects related to quality of life (visual functioning and psychosocial consequences). The points given to questions 1 to 8 and 9 to 16 are added to obtain 2 raw scores ranging from 8 to 24; one for visual functioning and one for appearance. Higher scores indicate better outcome. |
| Secondary | Percentage of participants with ≥8-degree increase from Baseline in motility (in at least 1 of 4 directions) in the study eye | Baseline and Week 24 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05524571
GET https://conductscience.org/api/trials/v1/NCT05524571/registered