Solrikitug for Eosinophilic Esophagitis
Recruiting in Palo Alto (17 mi)
+12 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Uniquity One (UNI)
Must be taking: PPI, STC
Must not be taking: Investigational drugs
Disqualifiers: Pregnancy, Crohn's, IBS, others
Prior Safety Data
Trial Summary
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.
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.
12345How 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.
12678Eligibility 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
+5 more
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.
+6 more
Trial 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
Participant Groups
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).
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Solrikitug mid doseExperimental Treatment1 Intervention
Solrikitug
Group II: Solrikitug low doseExperimental Treatment1 Intervention
Solrikitug
Group III: Solrikitug high doseExperimental Treatment1 Intervention
Solrikitug
Group IV: PlaceboPlacebo Group1 Intervention
Placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research Site 1039Dothan, AL
Research Site 1020Harrisburg, PA
Research Site 1006Plymouth, MN
Research Site 1015San Diego, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Uniquity One (UNI)Lead Sponsor
References
Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. [2023]Dupilumab, a fully human monoclonal antibody, blocks interleukin-4 and interleukin-13 signaling, which have key roles in eosinophilic esophagitis.
Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial. [2022]Eosinophilic esophagitis is a chronic allergic disease with insufficient treatment options. Results from animal studies suggest that IL-5 induces eosinophil trafficking in the esophagus.
The efficacy and safety of reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: A systematic review and meta-analysis. [2018]Reslizumab is a humanised anti-interleukin 5 monoclonal antibody that disrupts eosinophil maturation and promotes programmed cell death.
A pilot study of omalizumab in eosinophilic esophagitis. [2018]Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE), once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE) levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy.
Scientific journey to the first FDA-approved drug for eosinophilic esophagitis. [2023]When eosinophilia was first associated with esophagitis, it was thought to reflect gastroesophageal reflux disease, especially given the efficacy of reflux medications to abate esophageal eosinophilia in many individuals. Subsequent studies demonstrated disease remittance with amino acid-based formulas and conversely induction of esophageal eosinophilia in mice following allergen challenge. These results, along with the finding that proton pump inhibitors alleviated esophageal eosinophilia by an anti-inflammatory mechanism, turned attention away from an acid-induced pathogenesis and established eosinophilic esophagitis (EoE) as a separate disease entity driven by allergic inflammation. The disease underpinnings were elucidated by analysis of esophageal transcriptomic profiling, revealing gene signatures orchestrated by type 2 cytokine signaling, mainly IL-13. Preclinical studies showed that IL-13 overproduction was sufficient to induce EoE-like changes in mice and human ex vivo systems and conversely that inhibiting IL-13 signaling attenuated these processes. An early proof-of-principle study with a humanized anti-IL-13 mAb in patients with EoE revealed correction of the EoE transcriptome and attenuation of esophageal eosinophilia, providing a rationale for advancing anti-type 2 cytokine therapy for EoE. Dupilumab, a precision therapeutic mAb that blocks the shared IL-13 and IL-4 receptor, is the first drug to advance through clinical trials and receive US Food and Drug Administration approval for EoE. The ability of dupilumab to improve clinical, histologic, endoscopic, and molecular features of EoE and garner US Food and Drug Administration approval is a victory for science, rare diseases, patients, and advocacy and provides a framework for developing additional EoE treatments and approved treatments for eosinophilic gastrointestinal disease beyond the esophagus.
Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. [2022]The short-term efficacy of RPC4046, a monoclonal antibody against interleukin-13, has been shown in patients with eosinophilic esophagitis (EoE). We investigated the long-term efficacy and safety of RPC4046 in an open-label, long-term extension (LTE) study in adults with EoE.
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]DA-9701 (Motilitone) is a new prokinetic agent formulated with Corydalis Tuber and Pharbitis Seed. We assessed the efficacy of DA-9701 in symptomatic patients with minimal change esophagitis.
A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma. [2022]GSK3511294 is a humanized anti-interleukin (IL)-5 monoclonal antibody (mAb) engineered for extended half-life and improved IL-5 affinity versus other anti-IL-5 mAbs. This study examined its safety, tolerability, pharmacokinetics (PK) and effect on blood eosinophil counts.