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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

NI One Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Digestive System Diseases [C06]

Trial duration

4 Feb 2025 → ongoing

Decision date (initial)

2024-12-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

NI One Inc. (dba Uniquity One)

External identifiers

EU CT number

2024-510849-34-00

WHO UTN

U1111-1301-2903

ClinicalTrials.gov

NCT06598462

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Safety, Pharmacodynamic, Efficacy

Part A: To assess the efficacy of solrikitug, compared with placebo, on tissue inflammation and dysphagia symptoms in participants with EoE.
Part B: To assess the long-term safety and tolerability of solrikitug

Secondary objectives 1

1. The secondary objectives of the study are to evalute the safety and tolerability of solrikitug; to evaluate various markers of response in EoE, biomarkers, quality of life, immunogenicity and durability of response

Conditions and MedDRA coding

Eosinophilic Esophagitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1_Part A_ 18 to 75 years of age, inclusive, at the time of signing the informed consent
2. 2_Part A_Weigh >=40 kg at Screening
3. 3_Part A_ Documented diagnosis of EoE prior to or at Screening (Visit 1)
4. 4_Part A_ History of participant-reported weekly dysphagia in the last 4 weeks prior to Screening (Visit 1)
5. 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.
6. 6_Part A: Stable food diet in the last 8 weeks prior to Screening (Visit 1)
7. 8_Note Other Inclusion Criteria may apply

Exclusion criteria 4

1. 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;
2. 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
3. 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.
4. 3_Note - Other Exclusion criteria may apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. 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

Secondary endpoints 6

1. 1_ Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability
2. 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
3. 3_Various Patient Reported Outcomes and Quality of Life Measures for EoE at different timepoint during Part A and Part B)
4. 4_PartA: __Summaries of concentration time data for each treatment/dose level _Summaries of ADA titers and ADA and NAb incidence
5. 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
6. 7_PartB: __Listings and summary of concentration time data _Summaries of ADA titers and ADA and NAb incidence

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

NI One Inc.

Sponsor organisation

NI One Inc.

Address

1200 Atwater Drive Suite 105

City

Malvern

Postcode

19355-8782

Country

United States

Scientific contact point

Organisation

NI One Inc.

Contact name

Uniquity One

Public contact point

Organisation

NI One Inc.

Contact name

Uniquity One

Third parties 6

Locations

5 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 68 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications