A Study to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinophilic Esophagitis

You likely can't join if

• 1a_Part A: 1. Have a history or presence of any other clinically significant disease of the gastrointestinal tract, such as erosive esophagitis Grade B2 or above per the Los Angeles classification, eosinophilic gastritis, duodenitis, eosinophilic colitis, major motility disorder of the esophagus (e.g., achalasia), hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, or a history of esophageal surgery (e.g., fundoplication), Barrett’s esophagus, inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis), Celiac disease, significant hiatal hernia (e.g., clinically significant, symptomatic, non-sliding type, or >3 cm), cancer, or proctitis; 2. Have untreated and uncontrolled gastroesophageal reflux disease (GERD); 3. Have an active Helicobacter pylori infection; 4. Have a history of bleeding disorders, liver cirrhosis, or esophageal varices; 5. Have a current malignancy or previous history of cancer in remission for less than 5 years prior to Screening (Visit 1); 6. Have known or current serious infections or helminth infections; 7. Have known hypersensitivity to solrikitug or its excipients (e.g. polysorbate) 8. Have known or suspected immunosuppression, including HIV, a history of invasive opportunistic infections (e.g., tuberculosis, non-tuberculosis mycobacterial infections), or otherwise recurrent infections of abnormal frequency or prolonged infections suggesting an immunocompromised status, as judged by the Investigator; 9. Have been treated with an immunosuppression agent (e.g., systemic corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, or Janus-kinase inhibitors) within 3 months or 5 half-lives, whichever is longer, prior to Screening (Visit 1); 10. Are receiving allergen immunotherapy (SC immunotherapy), unless on a stable dose for at least 6 months prior to Screening (Visit 1); 11. Have been treated with oral immunotherapy or sublingual immunotherapy within 6 months prior to Screening (Visit 1); 12. Have received any live or attenuated vaccines within 1 month prior to Screening (Visit 1) or have plans to receive any live or attenuated vaccines during the study and for 3 months after end of treatment; 13. Have failed dupilumab treatment;
• 1b_14. Have received any investigational drug or approved biologic or biosimilar within 30 days or 5 half-lives prior to Screening (Visit 1), whichever is longer. Prior use of dupilumab is excluded for 130 days prior to Screening; 15. Have previously participated in a study with solrikitug or are currently participating in any interventional study with solrikitug; 16. Have any clinically relevant abnormal results in hematology, clinical chemistry, or urinalysis at Screening (Visit 1), or any clinically relevant abnormal findings in physical examination or vital signs during the Run-In Period, which, in the opinion of the Investigator, may put the participant at risk because of his or her participation in the study or may impact the results of the study or the participant’s ability to participate in the study; 17. Have alanine aminotransferase and/or aspartate aminotransferase levels >3 x upper limit of normal (ULN) at Screening (Visit 1); 18. Have total bilirubin >2 x ULN at Screening (Visit 1); 19. Have a positive hepatitis B surface antigen test or positive both total hepatitis B core antibody test and hepatitis B virus DNA test at Screening (Visit 1); 20. Have a positive hepatitis C virus antibody test at Screening (Visit 1), or have resolved hepatitis B or hepatitis C viral infection ; 21. Have QTcF >=450 msec for male participants and QTcF >=470 msec for female participants at Screening (Visit 1) based on local assessment; 22.Have a history or evidence of clinically significant cardiovascular disease (for example but not limited to coronary artery disease, ischemic heart disease, heart failure, stroke, myocardial infarction, cardiomyopathy, or ventricular tachycardia); 23. Have undergone esophageal dilation in the past 2 months prior to Screening (Visit 1), during screening EGD or have plans for dilation use during the study; 24. Have a significant stricture precluding passage of a >9 mm endoscope; 25. Have a history or suspected history of alcohol misuse or substance abuse within 12 months prior to Screening (Visit 1); or 26. Have a history or any other condition that, in the opinion of the Investigator, would interfere with the conduct of the study
• 2_Part B 1. Have developed a serious adverse event or adverse event (AE) deemed related to study drug, which in the opinion of the Investigator could indicate that continued treatment with study drug may present an unreasonable risk; 2. Have reported anaphylactic reaction to solrikitug; 3. Have received any live or attenuated vaccines within 1 month prior to Screening (Visit 1), have received any live or attenuated vaccines during Part A, during the 4 weeks prior to Part B, or have plans to receive any live or attenuated vaccines during Part 4. Did not undergo study designated endoscopy with biopsies in Part A 5. Have prematurely withdrawn due to Protocol violation, poor compliance, or inability to complete required study assessments in Part A.6. Have not received all doses of double-blind investigational product during Part A of the study or have not completed Week 24 assessments including endoscopy with biopsy; or 7. Female participants who became pregnant during Part A or are unwilling or unable to comply with Part B monthly pregnancy testing (Q4W) including testing between Visits 16 and 20 (Weeks 52 and 68); routine urine testing may be performed at home.
• 3_Note - Other Exclusion criteria may apply