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Lonigutamab for Thyroid Eye Disease (TED Trial)
Phase 1 & 2
Recruiting
Research Sponsored by ValenzaBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 169
Awards & highlights
TED Trial Summary
This trial tests a drug to treat thyroid eye disease. Volunteers receive either the drug or a placebo.
Who is the study for?
This trial is for men and women aged 18-70 with Thyroid Eye Disease (TED), showing eye protrusion and active symptoms within the last 15 months. Participants must have a Clinical Activity Score of at least 4, indicating active disease. They should not have had certain treatments for TED or conditions like inflammatory bowel disease, hearing loss, optic neuropathy, diabetes with high hemoglobin A1c levels, or recent steroid use.Check my eligibility
What is being tested?
The study tests Lonigutamab's effectiveness and safety in treating TED compared to a placebo. It's a Phase 1/2 trial where multiple doses are given to participants across various centers. The goal is to see if Lonigutamab can help reduce the severity of TED symptoms.See study design
What are the potential side effects?
While specific side effects for Lonigutamab aren't listed here, common side effects from similar treatments may include reactions at the injection site, headaches, muscle pains, possible immune system responses affecting different organs.
TED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 169
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 169
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and characterization of nonserious treatment emergent adverse events (TEAEs)
Incidence and characterization of serious treatment emergent adverse events (TEAEs)
Secondary outcome measures
PK profile of lonigutamab
TED Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.
Group II: Cohort 2Experimental Treatment2 Interventions
multiple doses of dose 2 of lonigutamab administered SC injection weekly
Group III: Cohort 1Experimental Treatment2 Interventions
Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
ValenzaBio, Inc.Lead Sponsor
2 Previous Clinical Trials
7 Total Patients Enrolled
ACELYRIN Inc.Lead Sponsor
8 Previous Clinical Trials
1,020 Total Patients Enrolled
Keenan, MDStudy DirectorValenzaBio, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition related to inflammation in the bowel or ongoing issues with your digestive system.You have a serious ear problem or have had trouble hearing in the past.You have a condition affecting your optic nerve.Your corneas are not responding to medical treatment.You have had radiation or surgery on your eye area before.You have diabetes or your hemoglobin A1c level is higher than 6.0%.You have been treated with drugs like rituximab or tocilizumab for thyroid eye disease.You have taken any other medication that weakens your immune system within the past month.You are between 18 and 70 years old.Your eye sticks out more than 3mm than it should.The most severely affected eye has a Clinical Activity Score (CAS) of 4 or higher on a 7-item scale.You have experienced symptoms of TED within the last 15 months before the start of the study.You have taken more than 3 grams of methylprednisolone for treating TED in the past year.You have not used more than 1 gram of steroids in the 8 weeks before the screening, specifically for treating TED.You have previously taken teprotumumab or any other IGF-1 receptor (IGF-1R) inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 2
- Group 3: Cohort 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the study accommodate younger participants, i.e., those under 40?
"This trial is limited to individuals aged 18-65 years old, as indicated by the inclusion parameters."
Answered by AI
Are any current opportunities available for individuals to enroll in this experiment?
"Indeed, according to the information available on clinicaltrials.gov, this research study is actively seeking participants. The trial was posted on January 1st 2023 and its details were last amended in December of that same year; it requires 36 patients from two locations for full enrollment."
Answered by AI
To what extent is the pool of participants being targeted by this experiment?
"Affirmative. The information hosted on clinicaltrials.gov suggests that this research project, which was first made available to the public on January 1st 2023, is still actively seeking participants. This study requires 36 people across 2 medical centres to take part in it."
Answered by AI
Am I qualified to participate in this experimental procedure?
"This clinical trial requires 36 participants with active Graves' ophthalmopathy to have the following criteria: gender (male or female), age 18-65, proptosis ≥3mm above normal, Clinical Activity Score of 4+ on a 7-item scale in their most affected eye, TED onset within 24 months prior to screening and agreement on highly effective contraception as per the protocol."
Answered by AI
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