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A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study with an Extension to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinophilic Esophagitis (ALAMERE)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510849-34-00
Acronym
NSI-8226-201
Enrollment
49
Registered
2024-12-02
Start date
2025-02-04
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Brief summary

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_Part B: _Incidence and severity of TEAEs _Safety data (e.g., clinical laboratory evaluations, vital signs, and 12-lead ECG results) _Injection site tolerability

Detailed description

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

Interventions

DRUGsolrikitug matching placebo

Sponsors

NI One Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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_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

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

Countries

Belgium, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026