Evaluation of K9 in Subjects with Thyroid Eye Disease (TED)

Launched by PETER TIMONEY · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called K9 for patients with Thyroid Eye Disease (TED), a condition that affects the eyes and is linked to thyroid problems. The trial is divided into two groups: the first group will help researchers understand how the medication works in healthy individuals, while the second group will focus on patients who have been diagnosed with active TED. Participants in the second group must have been diagnosed with TED within the last nine months and have noticeable symptoms.

Eligible participants for the trial should be between 18 and 80 years old and must be willing to receive treatment and complete assessments, including blood tests and eye exams. The study lasts for six weeks, during which participants may receive the medication just once or for up to four weeks. It's important to note that certain health conditions and treatments may prevent someone from joining the study, so potential participants should discuss their medical history with the research team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cohort 1
• • Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol
• • Cohort 2
• • Diagnosed with Thyroid Eye Disease (TED).
• • Symptomatic TED diagnosed no more than 9 months earlier.
• • Clinical Activity Score ≥ 3 (on 7 point scale) for the worse eye.
• • Subject is willing and able to receive treatment and complete corresponding assessments as required by the protocol.
• Exclusion Criteria:
• • Cohort 1
• • Body weight less than 55 kg.
• • History of any clinically significant medical disorders the principal investigator considers exclusionary, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
• • Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
• • History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
• • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary
• • Cohort 2
• • Body weight less than 55 kg.
• • Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception.
• • History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
• • Participation in any investigational drug or ocular device study within 30 days prior to the Day 1 Study Visit.
• • History or current evidence of a medical condition that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study.
• • Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
• • History of use of teprotumumab (Tepezza), radiotherapy, or orbital surgery.
• • History (last 6 weeks) of use of systemic (oral, intravenous, or intramuscular) corticosteroids or immunosuppressants (e.g. mycophenolate), intravenous immunoglobulin, or plasmapheresis.
• • Clinical activity score \< 3
• • Uncontrolled diabetes or hypertension
• • History of mental / psychiatric disorder
• • Hepatic dysfunction (Albumin (Alb), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility)
• • Renal impairment (Urea, Creatinine, and Glomerular Filtration Rate levels must be within normal range)
• • Any baseline condition that the principal investigator considers exclusionary.