A Phase 2a/b, randomized, double blind, placebo controlled, parallel group study to investigate the efficacy and safety of subcutaneous amlitelimab in adult patients with non responsive celiac disease as an adjunct to a gluten free diet

Conditions

Coeliac disease

Brief summary

Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28

Detailed description

Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score, Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI) during the placebo-controlled treatment period and the long-term extension, Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments during the placebo-controlled treatment period and the long-term extension, Percentage of participants discontinued from study treatment due to TEAEs during the placebo-controlled treatment period and the long-term extension, Serum amlitelimab concentrations measured at prespecified timepoints, Incidence of anti-drug antibodies (ADAs) of amlitelimab

Related papers

No related papers found yet.

Interventions

DRUGAmlitelimab

DRUGAmlitelimab matching placebo to test product

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score, Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI) during the placebo-controlled treatment period and the long-term extension, Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments during the placebo-controlled treatment period and the long-term extension, Percentage of participants discontinued from study treatment due to TEAEs during the placebo-controlled treatment period and the long-term extension, Serum amlitelimab concentrations measured at prespecified timepoints, Incidence of anti-drug antibodies (ADAs) of amlitelimab	—

Measure

Time frame

Change in Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) symptom severity score, Percentage of participants who experienced treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESI) during the placebo-controlled treatment period and the long-term extension, Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments during the placebo-controlled treatment period and the long-term extension, Percentage of participants discontinued from study treatment due to TEAEs during the placebo-controlled treatment period and the long-term extension, Serum amlitelimab concentrations measured at prespecified timepoints, Incidence of anti-drug antibodies (ADAs) of amlitelimab

—

Primary

Measure	Time frame
Change in Villus Height to Crypt Depth Ratio (Vh:Cd) from baseline to Week 28	—

Countries

Belgium, Czechia, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Slovakia, Spain, Sweden

Outcome results

None listed