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An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED)

ConditionThyroid Eye Disease
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanjing Chia-tai Tianqing Pharmaceutical

About this trial

Multicentre, Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of NTB003 in Participants with Thyroid Eye Disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Male or female subjects aged 18-75 years who have signed informed consent. 2.Body weight between 40 kg and 100 kg. 3.Clinical diagnosis of thyroid eye disease (TED): Active thyroid eye disease (TED): at least one eye with a CAS ≥ 3 and proptosis ≥ 3 mm above the upper limit of normal in that eye, and the subject's first onset of TED ocular signs/symptoms (by subject report or medical records) occurred within 1 year prior to first study drug administration; Chronic Thyroid Eye Disease (TED) : bilateral CAS < 3, and the first onset of TED ocular signs/symptoms (by subject report or medical records) occurred > 12 months prior to first study drug administration.

Disqualifiers

1. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period.

Trial design

Design model

Sequential

Treatments tested in this trial

  • NTB003

    Drug

    NTB003 dose 1 administered SC injection every 4 weeks.

  • NTB003

    Drug

    NTB003 dose 2 administered SC injection every 4 weeks.

  • NTB003

    Drug

    NTB003 dose 3 administered SC injection every 4 weeks.

  • NTB003 and Placebo

    Drug

    Drug:NTB003 subcutaneous injection Drug: Placebo subcutaneous injection

Treatment groups

74 Participants
are divided into 4 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention
Group D: Cohort 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proptosis Responder Rate in the study eye

Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline \[without a corresponding increase of ≥ 2 mm in the fellow eye\] as measured by exophthalmometer)

Time frame
Week 12

Secondary outcomes

1

Change from baseline in proptosis in the study eye

Change from baseline in proptosis in the study eye as measured by exophthalmometer

Time frame
Baseline, up to Week 24
2

Change from baseline in CAS

Change from baseline in Clinical Activity Score (CAS) in the study eye；

Time frame
Baseline, up to Week 24
3

Overall Responder Rate

Overall Responder Rate comprising Proptosis Responder Rate as measured by exophthalmometer and Clinical Activity Responder Rate in the study eye

Time frame
up to Week 24
4

Diplopia response rate

The percentage of subjects with a reduction in diplopia severity by ≥1 grade.

Time frame
up to Week 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Chia-tai Tianqing Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: