Solrikitug for Eosinophilic Esophagitis

Recruiting at 60 trial locations

Overseen By Uniquity One

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Uniquity One (UNI)

Must be taking: PPI, STC

Must not be taking: Investigational drugs

Disqualifiers: Pregnancy, Crohn's, IBS, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

157 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called solrikitug, a humanized monoclonal antibody, for individuals with eosinophilic esophagitis (EoE), a condition that can make swallowing difficult. The trial aims to assess the safety and tolerability of solrikitug, as well as how the body processes it. Participants will receive either a placebo or one of three different doses of solrikitug. This trial suits those diagnosed with EoE who experience swallowing issues at least twice a week and have maintained a stable diet for at least eight weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You can continue taking your current medications like PPIs (medications that reduce stomach acid) and STCs (swallowed topical corticosteroids) as long as they have been stable for at least 8 weeks before the study and you agree not to change them unless necessary. However, you must stop any investigational drugs or biologics at least 30 days before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that solrikitug was tested for safety in earlier studies. These studies examined how well participants tolerated the treatment and identified any side effects. Initial results suggested that solrikitug was generally well-tolerated, with no major safety issues reported. However, some participants experienced minor side effects, which is common in clinical trials. As this current study is in an early phase, further research is needed to fully understand the safety of solrikitug. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for eosinophilic esophagitis?

Researchers are excited about Solrikitug for eosinophilic esophagitis because it offers a novel mechanism of action compared to current treatments. While standard options often involve corticosteroids that suppress inflammation broadly, Solrikitug specifically targets and reduces eosinophil levels, which are the cells primarily responsible for the condition. This targeted approach could potentially lead to fewer side effects and more effective management of the esophagus inflammation. Moreover, Solrikitug is being tested at different doses (low, mid, and high), which may help optimize treatment effectiveness and tailor it to individual patient needs.

What evidence suggests that solrikitug might be an effective treatment for eosinophilic esophagitis?

Research suggests that solrikitug may help treat eosinophilic esophagitis (EoE). EoE is a condition where the esophagus becomes inflamed due to high levels of eosinophils, white blood cells involved in allergic reactions. Studies have shown that treatments like solrikitug, which target the immune system, can lower eosinophil levels in the esophagus. This reduction can decrease inflammation and relieve symptoms. Some early evidence indicates that solrikitug can improve the condition for people with EoE, but more research is needed to confirm its effectiveness. Participants in this trial will receive either a low, mid, or high dose of solrikitug, or a placebo, to further evaluate its effectiveness. ^{2 3 4 5 6}

Who Is on the Research Team?

Andrew W Lee, MD

Principal Investigator

Vice President, Clinical Research

Are You a Good Fit for This Trial?

This trial is for adults with Eosinophilic Esophagitis, a condition where eosinophils build up in the esophagus causing inflammation and difficulty swallowing. Participants should meet certain health standards but specific inclusion and exclusion criteria are not listed.

Inclusion Criteria

I have been diagnosed with EoE through a biopsy.

I have had trouble swallowing at least twice a week in the last month.

Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study

Exclusion Criteria

I am currently pregnant or breastfeeding.

Participants who became pregnant during Part A

I haven't had an endoscopy before starting my current treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive solrikitug or placebo via subcutaneous injection over a 24-week period

24 weeks

Open-label extension

Participants may continue to receive solrikitug in an open-label extension for 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Solrikitug

Trial Overview The study tests different doses of Solrikitug against a placebo to see if it's safe and effective for treating Eosinophilic Esophagitis. It will also look at how the body processes the drug (pharmacokinetics) and its effects on the immune system (immunogenicity).

How Is the Trial Designed?

Group I: Solrikitug mid dose Experimental Treatment 1 Intervention

Solrikitug

Group II: Solrikitug low dose Experimental Treatment 1 Intervention

Solrikitug

Group III: Solrikitug high dose Experimental Treatment 1 Intervention

Solrikitug

Group IV: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Uniquity One (UNI)

Lead Sponsor

Trials

5

Recruited

490+

Published Research Related to This Trial

In a long-term study involving 66 adults with eosinophilic esophagitis (EoE), RPC4046, a monoclonal antibody targeting interleukin-13, demonstrated sustained efficacy over 52 weeks, with symptom remission increasing significantly from 14% to 67% in patients who initially received placebo.

RPC4046 was generally well tolerated, with the most common side effects being upper respiratory tract infections and nasopharyngitis, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. Dellon, ES., Collins, MH., Rothenberg, ME., et al.[2022]

In a phase 3 trial involving patients aged 12 and older, weekly administration of dupilumab led to histologic remission in 60% of patients, significantly outperforming placebo, which had only a 5% remission rate.

Dupilumab also improved symptoms of eosinophilic esophagitis, as indicated by a substantial reduction in Dysphagia Symptom Questionnaire scores compared to placebo, demonstrating its efficacy in both histological and symptomatic relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. Dellon, ES., Rothenberg, ME., Collins, MH., et al.[2023]

In a pilot study of 15 patients with Eosinophilic Esophagitis (EoE), treatment with the anti-IgE drug omalizumab for 12 weeks significantly reduced tissue IgE levels and showed a correlation between decreased eosinophils and clinical improvement, although full remission was achieved in only 33% of patients.

The study suggests that omalizumab may be effective for EoE in patients with low peripheral blood eosinophil counts, highlighting the need for further research to confirm these findings in a larger, controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of omalizumab in eosinophilic esophagitis. Loizou, D., Enav, B., Komlodi-Pasztor, E., et al.[2018]

Eosinophilic esophagitis (EoE) is now recognized as a distinct disease driven by allergic inflammation, particularly linked to IL-13 signaling, rather than being solely caused by acid reflux, as shown by various studies including transcriptomic profiling.

Dupilumab, an anti-IL-13 and IL-4 receptor monoclonal antibody, has been approved by the FDA for EoE, demonstrating significant improvements in clinical and molecular features of the disease, marking a significant advancement in treatment options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scientific journey to the first FDA-approved drug for eosinophilic esophagitis. Rothenberg, ME.[2023]

GSK3511294, an anti-IL-5 monoclonal antibody, was well tolerated in a Phase 1 study with 48 asthma patients, showing no serious adverse events and a low incidence of hypersensitivity and injection-site reactions.

The treatment led to significant reductions in blood eosinophil counts (over 48% within 24 hours) that were maintained longer with higher doses, indicating its potential for less frequent dosing compared to other anti-IL-5 therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma. Singh, D., Fuhr, R., Bird, NP., et al.[2022]

In a study involving 81 patients with minimal change esophagitis, DA-9701 did not show a significant improvement in symptom scores or quality of life compared to a placebo after 4 weeks of treatment.

However, patients aged 65 years or older did experience a significant improvement in reflux symptoms when treated with DA-9701, suggesting potential benefits for older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the New Prokinetic Agent DA-9701 Formulated With Corydalis Tuber and Pharbitis Seed in Patients With Minimal Change Esophagitis: A Bicenter, Randomized, Double Blind, Placebo-controlled Study. Park, CH., Kim, HS., Lee, SK.[2022]

Reslizumab, an IL-5 neutralizing antibody, significantly reduced peak esophageal eosinophil counts by 59% to 67% in children and adolescents with eosinophilic esophagitis, based on a study involving 226 patients.

Despite the reduction in eosinophil counts, symptom improvements were noted in all treatment groups, including placebo, indicating that symptom relief may not be directly linked to eosinophil levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial. Spergel, JM., Rothenberg, ME., Collins, MH., et al.[2022]

Reslizumab significantly reduces asthma exacerbations and improves lung function in patients with inadequately controlled eosinophilic asthma, as shown by a meta-analysis of 5 randomized controlled trials.

The treatment is well tolerated, with no significant increase in adverse events leading to withdrawal, indicating its safety for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: A systematic review and meta-analysis. Li, J., Wang, F., Lin, C., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-2-esophagitis-9-2024-af870

Solrikitug for Eosinophilic Esophagitis The study suggests that omalizumab may be effective for EoE in patients with low peripheral blood eosinophil counts, highlighting the need for further research ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S155171442400291X

Design of a phase 3, randomized, double-blind, placebo ... This phase 3 pivotal study will determine whether cendakimab provides an effective, safe, targeted treatment for patients with EoE.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT04753697/Prot_SAP_000.pdf

Official Title of Study: A Phase 3, Multicenter, Multinational, ... humanized, high-affinity neutralizing (immunoglobulin G1 kappa [IgG1κ]) monoclonal antibody. (mAb) selective for interleukin-13 (IL-13). CC ...

4. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/1910/phase-3-multi-center-multi-national/

Clinical Research Studies - NYU CC-93538 180 mg and 360 mg subcutaneously (SC) weekly for 16 weeks reduced the mean esophageal eosinophil count (the primary endpoint) and improved other ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06598462/a-study-to-investigate-the-efficacy-and-safety-of-nsi-8226-in-adults-with-eosinophilic-esophagitis

A Study to Investigate the Efficacy and Safety of NSI-8226 ... Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/533456

A Study to Investigate the Efficacy and Safety of NSI-8226 ... Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with ...