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Not yet recruiting NCT06769984

A Study of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease.

Phase I / Phase II Interventional TED

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCTT11, Placebo.
Who it may be relevant to
Registry conditions: TED. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Moderate-to-severe Thyroid Eye Disease

Overview

Multicentre, Randomized, Double-blinded, Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease

Interventions

  • Drug SCTT11
    SCTT11 dose 1, dose 2, dose 3, dose 4
  • Drug Placebo
    Placebo dose 1, dose 2, dose 3, dose 4

Primary outcome measures

  • The occurrences of treatment-emergent adverse events (TEAE), treatment-related TEAE (TRAE), serious adverse events (SAE), and adverse events of special interest (AESI) [Time frame: Day 0 up to 85 days for healthy participants]
  • Proptosis Responder Rate in the study eye [Time frame: Day 0 up to 169 days]
Secondary outcome measures (6)
  • Change from baseline in proptosis in the study eye as measured by exophthalmometer [Time frame: Day 0 up to 169days]
  • Change from baseline in Clinical Activity Score (CAS) [Time frame: Day 0 up to 169days]
  • Diplopia Responder Rate [Time frame: Day 0 up to 169days]
  • Proportion of participants with a CAS of zero or one in the study eye [Time frame: Day 0 up to 169days]
  • SCTT11 concentrations in the blood over time [Time frame: Day 0 up to 169days]
  • Incidence of anti-drug antibody (ADA) development in SCTT11-treated participants over time [Time frame: Day 0 up to 169days]

Eligibility criteria

Inclusion Criteria for Healthy Participants:

  • Healthy male or female participants aged between18 and 45 inclusive
  • All participants must agree to not fall pregnant and voluntarily use highly effective double method contraception during the study for at least 180 days after the last dose; female participants must have a negative pregnancy test prior to dosing and must not be breastfeeding

Exclusion Criteriafor Healthy Participants:

1.With any other disease or medical condition of clinical significance (e.g., past medical history of chronic hepatic, renal, cardiovascular, neurological/psychiatric, gastrointestinal, respiratory, urological, endocrinological, or other systemic diseases, etc.) as assessed by the investigator.

Inclusion Criteria for TED Participants:

  • Male or female participants aged between 18 and 70 inclusive
  • Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED
  • Normal thyroid function, or only mild hyperthyroidism or hypothyroidism (defined as screening free triiodothyronine \[FT3\] and free thyroxine \[FT4\] levels < 50% above or below the normal limits).

Exclusion Criteria for TED Participants:

  • Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose
  • Corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator
  • 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
  • Presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results
  • Presence of poorly controlled diabetes mellitus
  • The current presence of other uncontrolled clinical diseases or conditions
  • Abnormalities in any of the following laboratory examinations during the screening phase
  • Poorly controlled hypertension
  • With past medical histories of major surgery and/or trauma within 1 month prior to the first dose
  • With past medical histories of severe allergies, histories of severe drug allergies, known or suspected allergy to any component of this investigational product
  • Vaccination with live or live attenuated vaccine within 1 month prior to the first dose or expected during the study
  • Participation in a clinical study of any drug or device within 3 months prior to the first dose and have used the investigational product or have been treated with the device
  • Pregnant, lactating females; or participants of childbearing potential who are unwilling to use effective contraception during the study and within 180 days after the last dose
  • Other conditions evaluated by the investigator to be unsuitable for enrolment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06769984 · SCTT11-X201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗