SOLRIKITUG for Eosinophilic esophagitis

Inclusion criteria

• {"criterion_text":"- 1_Part A_ 18 to 75 years of age, inclusive, at the time of signing the informed consent\n- 2_Part A_Weigh >=40 kg at Screening\n- 3_Part A_ Documented diagnosis of EoE prior to or at Screening (Visit 1)\n- 4_Part A_ History of participant-reported weekly dysphagia in the last 4 weeks prior to Screening (Visit 1)\n- 5_Have previously documented standard of care (SOC) treatment of an adequate trial of proton pump inhibitors (PPIs) per current clinical treatment guidelines for EoE. Other SOC treatment may include swallowed topical corticosteroids (STCs), and/or diet modification. If the SOC treatment is only indicated for a short-term course (e.g., STC for up to 12 weeks), the participant is intolerant of SOC, the participant is non-adherent, or if SOC results in a sub optimal response, it should be discontinued for at least the following periods of washout prior to Screening (Visit 1): a.PPIs: 5 effective half-lives or 3 days; and b. STCs: 8 weeks. However, if in the opinion of the Investigator, it is determined to be medically necessary to continue SOC, the dose and treatment regimen must be stable (i.e., no dose change and participant compliance over at least 8 weeks) and the participant must be willing to adhere to the treatment regimen throughout the study duration. Concomitant use of dupilumab is not permitted during study.\n- 6_Part A: Stable food diet in the last 8 weeks prior to Screening (Visit 1)\n- 8_Note Other Inclusion Criteria may apply"}

Exclusion criteria

• {"criterion_text":"- 1a_Part A: 1.\tHave 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.\tHave untreated and uncontrolled gastroesophageal reflux disease (GERD); 3.\tHave an active Helicobacter pylori infection; 4.\tHave a history of bleeding disorders, liver cirrhosis, or esophageal varices; 5.\tHave a current malignancy or previous history of cancer in remission for less than 5 years prior to Screening (Visit 1); 6.\tHave known or current serious infections or helminth infections; 7. Have known hypersensitivity to solrikitug or its excipients (e.g. polysorbate) 8.\tHave 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.\tHave 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.\tAre receiving allergen immunotherapy (SC immunotherapy), unless on a stable dose for at least 6 months prior to Screening (Visit 1); 11.\tHave been treated with oral immunotherapy or sublingual immunotherapy within 6 months prior to Screening (Visit 1); 12.\tHave 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.\tHave failed dupilumab treatment;"}
• {"criterion_text":"- 1b_14.\tHave 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.\tHave previously participated in a study with solrikitug or are currently participating in any interventional study with solrikitug; 16.\tHave 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.\tHave alanine aminotransferase and/or aspartate aminotransferase levels >3 x upper limit of normal (ULN) at Screening (Visit 1); 18.\tHave total bilirubin >2 x ULN at Screening (Visit 1); 19.\tHave 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.\tHave a positive hepatitis C virus antibody test at Screening (Visit 1), or have resolved hepatitis B or hepatitis C viral infection ; 21.\tHave 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.\tHave 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.\tHave a significant stricture precluding passage of a >9 mm endoscope; 25.\tHave a history or suspected history of alcohol misuse or substance abuse within 12 months prior to Screening (Visit 1); or 26.\tHave a history or any other condition that, in the opinion of the Investigator, would interfere with the conduct of the study"}
• {"criterion_text":"- 2_Part B 1.\tHave 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.\tHave reported anaphylactic reaction to solrikitug; 3.\tHave 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.\tDid not undergo study designated endoscopy with biopsies in Part A 5.\tHave prematurely withdrawn due to Protocol violation, poor compliance, or inability to complete required study assessments in Part A.6.\tHave 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.\tFemale 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."}
• {"criterion_text":"- 3_Note - Other Exclusion criteria may apply"}

Primary endpoints

• {"endpoint_text":"- 1_Part A: _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 6 eos/HPF at Week 24 _Change in DSQ total score from baseline to Week 24","definition_or_measurement_approach":"Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with ≤6 eos/HPF at Week 24; DSQ (Dysphagia Symptom Questionnaire) total score change measured from baseline to Week 24."}
• {"endpoint_text":"- 2_Part B: _Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability","definition_or_measurement_approach":"Safety endpoints include incidence and severity of treatment-emergent adverse events (TEAEs); clinical laboratory evaluations, vital signs, and 12-lead ECG results; and injection-site tolerability assessments as recorded during Part B."}

Secondary endpoints

• {"endpoint_text":"- 1_ Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability","definition_or_measurement_approach":"As above: incidence/severity of TEAEs; standard safety data (labs, vitals, 12-lead ECG); injection-site tolerability monitoring."}
• {"endpoint_text":"- 2_PartA: _Peak eosinophil count per HPF in biopsy specimens as measured by the proportion of participants with <=15 eos/HPF at Week 24 _Percent change in peak eosinophil count from baseline to Week 24","definition_or_measurement_approach":"Histologic endpoints: proportion of participants with ≤15 eos/HPF at Week 24; percent change in peak eosinophil count from baseline to Week 24."}
• {"endpoint_text":"- 3_Various Patient Reported Outcomes and Quality of Life Measures for EoE at different timepoint during Part A and Part B)","definition_or_measurement_approach":"Patient-reported outcome instruments and quality-of-life measures for EoE assessed at prespecified timepoints during Part A and Part B (instruments not further specified in the record)."}
• {"endpoint_text":"- 4_PartA: __Summaries of concentration time data for each treatment/dose level _Summaries of ADA titers and ADA and NAb incidence","definition_or_measurement_approach":"Pharmacokinetic summaries (concentration vs time) for each treatment/dose level; summaries of anti-drug antibody (ADA) titers and incidence of ADA and neutralizing antibodies (NAb)."}
• {"endpoint_text":"- 6_PartB: _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 6 eos/HPF and the change in DSQ total score from Week 24 to Week 52 _Percent change in peak eosinophil count from Week 24 to Week 52 _Peak eosinophil count per HPF in biopsy specimens measured by the proportion of participants with <= 15 eos/HPF from Week 24 to Week 52","definition_or_measurement_approach":"Histologic and symptom durability endpoints comparing Week 24 to Week 52: proportions meeting specified eosinophil thresholds (≤6 and ≤15 eos/HPF), change in DSQ total score, and percent change in peak eosinophil count."}
• {"endpoint_text":"- 7_PartB: __Listings and summary of concentration time data _Summaries of ADA titers and ADA and NAb incidence","definition_or_measurement_approach":"Part B summaries: concentration-time data listings and summaries; ADA titers and ADA/NAb incidence reporting for longer-term follow-up."}

Methods

• Participant brochure (K2_Recruitment material_Brochure in EN/FR/DU and country-specific brochures)
• Participant flyer (K2_Recruitment material_Flyer in EN/FR/DU and country-specific flyers)
• Website content (K2_Recruitment material_Website in multiple languages)
• Participant Journey materials (K2_Recruitment material_Journey) describing pathway and retention
• Recruitment arrangements documents (K1_Recruitment arrangements) with country-specific versions (BE, ES, IT, NL, PL)
• Retention items and participant-facing materials (e.g., Patient Card, GP Letter) listed in recruitment documents

Belgium

Earliest CTIS Part Ii Submission Date

04-11-2024

Latest Decision Or Authorization Date

03-12-2024

Processing Time Days

29

Number Of Sites

3

Number Of Participants

4

Spain

Earliest CTIS Part Ii Submission Date

22-11-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

10

Number Of Sites

4

Number Of Participants

9

Italy

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

04-12-2024

Processing Time Days

16

Number Of Sites

9

Number Of Participants

16

Netherlands

Earliest CTIS Part Ii Submission Date

19-11-2024

Latest Decision Or Authorization Date

09-12-2024

Processing Time Days

20

Number Of Sites

3

Number Of Participants

6

Poland

Earliest CTIS Part Ii Submission Date

20-11-2024

Latest Decision Or Authorization Date

09-12-2024

Processing Time Days

19

Number Of Sites

8

Number Of Participants

14

Primary sponsor

Full Name

NI One Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

QPS LLC

Responsibilities

sponsorDuties codes: [4]

Name

Precision For Medicine Inc.

Responsibilities

sponsorDuties codes: [4]

Name

Medpace Finland Oy

Responsibilities

sponsorDuties codes: [1,10,11,12,13,2,3,4,5,6,7,8]

Third parties

• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cincinnati Childrens Hospital Medical Center","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"long term storage of biological samples (sponsorDuties code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Thermo Fisher Scientific Inc.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes: [1,10,11,12,13,2,3,4,5,6,7,8]","organisation_type":"Pharmaceutical company"}