Solrikitug for Eosinophilic Esophagitis

Recruiting at 12 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

Trial Summary

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.

What data supports the effectiveness of the drug Solrikitug for eosinophilic esophagitis?

Research on similar treatments, like dupilumab, shows that blocking certain proteins involved in allergic reactions can help reduce symptoms of eosinophilic esophagitis. This suggests that Solrikitug, which targets a related protein, might also be effective. ^{1 2 3 4 5}

How is the drug Solrikitug different from other treatments for eosinophilic esophagitis?

Solrikitug is unique because it targets the cytokine receptor like factor 2 (CRLF2), which is different from other treatments that often target interleukins like IL-4, IL-5, or IL-13. This makes it a novel approach in managing eosinophilic esophagitis by potentially addressing a different pathway involved in the disease. ^{1 2 6 7 8}

What is the purpose of this trial?

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.

Research Team

Andrew W Lee, MD

Principal Investigator

Vice President, Clinical Research

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial. [2022]

3. England 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A pilot study of omalizumab in eosinophilic esophagitis. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. [2022]

7. Korea (South) 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma. [2022]