~6 spots leftby May 2025

Lonigutamab for Thyroid Eye Disease (TED Trial)

Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: ValenzaBio, Inc.
No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new medication called lonigutamab to help people with Thyroid Eye Disease (TED). TED causes eye problems due to thyroid issues. Lonigutamab may work by reducing inflammation and other symptoms in the eyes.
Is the drug Lonigutamab a promising treatment for Thyroid Eye Disease?Yes, Lonigutamab, which is similar to teprotumumab, shows promise as a treatment for Thyroid Eye Disease. Teprotumumab, a drug targeting the same receptor, has been effective in reducing symptoms and has been approved by the FDA. This suggests that Lonigutamab could also be a promising option.13457
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you've used steroids for TED above certain doses, IGF-1R inhibitors, biologic drugs for TED, or any immunosuppressive agents within a month of screening.
What data supports the idea that Lonigutamab for Thyroid Eye Disease is an effective drug?The available research does not provide specific data on Lonigutamab for Thyroid Eye Disease. Instead, it focuses on another drug called Teprotumumab, which has been shown to significantly reduce symptoms of Thyroid Eye Disease. This includes reducing eye bulging and improving eye movement. There is no direct evidence from the provided research articles to support the effectiveness of Lonigutamab for this condition.12568
What safety data is available for Lonigutamab in treating Thyroid Eye Disease?The provided research does not contain specific safety data for Lonigutamab (also known as VB421, VB-421, or anti-IGF-1R monoclonal antibody) in the treatment of Thyroid Eye Disease. The studies focus on teprotumumab, another IGF-1R antibody, which has been evaluated for safety in clinical trials for Thyroid Eye Disease. Teprotumumab was found to have an acceptable safety profile in phase 1 studies for malignancies and was further evaluated in phase 2 and 3 trials for Thyroid Eye Disease, showing superiority over placebo in efficacy. However, specific safety data for Lonigutamab is not mentioned in the provided research.14578

Eligibility Criteria

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.

Treatment Details

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.
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks.
Group II: Cohort 3Experimental Treatment2 Interventions
multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks.
Group III: Cohort 2Experimental Treatment2 Interventions
multiple doses of dose 2 of lonigutamab administered SC injection weekly
Group IV: Cohort 1Experimental Treatment2 Interventions
Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21

Find a clinic near you

Research locations nearbySelect from list below to view details:
Clinical Research SiteBeverly Hills, CA
Clinical Research SiteNew York City, NY
Clinical Research SiteAtlanta, GA
Clinical Research SiteJacksonville, FL
More Trial Locations
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Who is running the clinical trial?

ValenzaBio, Inc.Lead Sponsor
ACELYRIN Inc.Lead Sponsor

References

Treatment of active corticosteroid-resistant graves' orbitopathy. [2022]To assess the efficacy of Tocilizumab, a humanized monoclonal antibody against the interleukin-6 receptor, in thyroid eye disease patients refractory to multiple intravenous steroids.
Teprotumumab for non-inflammatory thyroid eye disease (TED): evidence for increased IGF-1R expression. [2022]Teprotumumab, a blocking antibody to the insulin like growth factor 1 receptor (IGF-1R) has been shown to significantly reduce proptosis in recent phase 2 and 3 trials in patients with inflammatory thyroid eye disease (TED). Herein, we investigate the impact of teprotumumab on patients with non-inflammatory TED. We also investigate the expression of the IGF-1R on orbital tissues from patients with inflammatory and non-inflammatory TED compared to controls.
Teprotumumab as a Novel Therapy for Thyroid-Associated Ophthalmopathy. [2021]Thyroid-associated ophthalmopathy (TAO) has remained a vexing and poorly managed autoimmune component of Graves' disease where the tissues surrounding the eye and in the upper face become inflamed and undergo remodeling. This leads to substantial facial disfigurement while in its most severe forms, TAO can threaten eye sight. In this brief paper, I review some of the background investigation that has led to development of teprotumumab as the first and only US FDA approved medical therapy for TAO. This novel treatment was predicated on recognition that the insulin-like growth factor I receptor plays an important role in the pathogenesis of TAO. It is possible that a similar involvement of that receptor in other autoimmune disease may lead to additional indications for this and alternative insulin-like growth factor I receptor-inhibiting strategies.
Teprotumumab: Interpreting the Clinical Trials in the Context of Thyroid Eye Disease Pathogenesis and Current Therapies. [2021]Teprotumumab, a monoclonal antibody targeted against the insulin-like growth factor 1 (IGF-1) receptor, was recently approved by the United States Food and Drug Administration for the treatment of thyroid eye disease (TED). Phase 1 studies of teprotumumab for the treatment of malignancies demonstrated an acceptable safety profile but limited effectiveness. Basic research implicating the IGF-1 receptor on the CD-34+ orbital fibrocyte in the pathogenesis of TED renewed interest in the drug. Two multicenter, randomized, double-masked, clinical trials (phase 2 and 3) evaluated the efficacy of 8 infusions of teprotumumab every 3 weeks versus placebo in 170 patients with recent-onset active TED, as defined by a clinical activity score (CAS) of at least 4. Teprotumumab was superior to placebo for the primary efficacy end points in both studies: overall responder rate as defined by a reduction of 2 or more CAS points and a reduction of 2 mm or more in proptosis (69% vs. 20%; P
Teprotumumab for the treatment of chronic thyroid eye disease. [2022]Teprotumumab, a novel IGF-1R antibody was recently shown to significantly reduce the signs of active Thyroid eye disease (TED). The current study reviews its efficacy in chronic TED.
Reduction in Extraocular Muscle Cross-sectional Area and Correlation With Extraocular Motility and Diplopia Following Teprotumumab for Thyroid Eye Disease. [2023]To quantify changes in extraocular muscle (EOM) cross-sectional areas (CSA) on orbital imaging in patients with thyroid eye disease before and after teprotumumab treatment, and assess for correlation with clinical outcomes.
Efficacy of teprotumumab therapy in patients with long-duration thyroid eye disease. [2023]Teprotumumab, an inhibitor of the insulin-like growth factor 1 receptor (IGF-1R), was approved by the US Food and Drug Administration in January 2020 for the treatment of thyroid eye disease (TED). The clinical trials leading to its approval enrolled patients with recent disease onset and significant inflammatory symptoms and signs. Subsequent real-world teprotumumab use in patients with longer duration of disease also may be effective, and there have been several publications reporting on experience in these patient groups.
Teprotumumab-Related Adverse Events in Thyroid Eye Disease: A Multi-Center Study. [2023]To assess the duration, incidence, reversibility, and severity of adverse events (AEs) in patients with thyroid eye disease (TED) treated with teprotumumab.