JRCT ID: jRCT2021210067
Registered date:02/02/2022
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITIS
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Eosinophilic gastroenteritis |
Date of first enrollment | 04/03/2022 |
Target sample size | 45 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | CC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescents of 12 years of age or older.After 16 weeks after the initial administration,a dose of 360 mg is administered subcutaneously weekly or bi-weekly.During the OLE phase,360 mg will be administered subcutaneously weekly. |
Outcome(s)
Primary Outcome | Primary Outcome Measure: 1. Changes in mean number of peak eosinophils (eos) per high-power field (hpf) in gastrointestinal (GI) biopsies from baseline to Week 16 [Time Frame: At Week 16] |
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Secondary Outcome | Secondary Outcome Measure: 2. Incidence of clinical response: eosinophilic gastroenteritis (EGE) related symptoms with changes from baseline in the five domain scores of the Izumo Scale from baseline [Time Frame: Up to 48 weeks] 3. Incidence of clinical response composite: proportion of participants who achieve < 4/15 in each of three Symptoms of Interest scores of the Izumo Scale from baseline [Time Frame: Up to 48 weeks] 4. Incidence of histologic response composite: proportion of participants with a > 75% reduction of peak gastric and/or duodenal eos count from baseline [Time Frame: Up to 48 weeks] 5. Incidence of adverse events (AEs) [Time Frame: Up to 48 weeks] 6. Incidence of serious adverse events [Time Frame: Up to 48 weeks] 7. Number of participants with clinical laboratory abnormalities [Time Frame: Up to 48 weeks] 8. Number of participants with electrocardiogram abnormalities [Time Frame: Up to 48 weeks] 9. Number of participants with vital sign abnormalities [Time Frame: Up to 48 weeks] 10. Number of participants with physical examination abnormalities [Time Frame: Up to 48 weeks] 11. Number of participants with the presence of anti-drug antibodies, including neutralizing antibodies [Time Frame: Up to 48 weeks] 12. Eosinophil histologic response: changes in mean number of peak eos per hpf in GI biopsies [Time Frame: Up to 48 weeks] 13. Eosinophil histologic response: percent changes in mean number of peak eos per hpf in GI biopsies from baseline [Time Frame: Up to 48 weeks] 14. Clinical response: eosinophilic gastrointestinal disorder (EGID) Severity Score [Time Frame: Up to 48 weeks] 15. Time to event: the time to event of EGE flare [Time Frame: Up to 48 weeks] 16. Time to event: the time to event of use of rescue therapy [Time Frame: Up to 48 weeks] 17. Time to event: The time until concomitant corticosteroid use to zero For participants who use concomitant treatment only [Time Frame: Up to 48 weeks] 18. Proportion of participants with event: The proportion of participants for whom the dose of concomitant steroids is reduced to zero For participants who use concomitant treatment only [Time Frame: Up to 48 weeks] 19. Pharmacokinetics: Trough concentrations of CC-93538 [Time Frame: Up to 48 weeks] |
Key inclusion & exclusion criteria
Age minimum | >= 12age old |
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Age maximum | <= 75age old |
Gender | Both |
Include criteria | - Histologic evidence of eosinophilic gastroenteritis (EGE) defined as >- 30 eosinophils (eos)/high-power field (hpf) in at least 5 hpf in the stomach and/or >- 30 eos/hpf in at least 3 hpf in the duodenum while on stable background therapy for EGE - Has weekly symptom scores of >- 4/15 for any of Gastric Pain Symptoms domain, Stomach Heaviness Symptom domains, and /or Diarrhea Symptoms domain as assessed by the Izumo Scale with electronic device for the 2 consecutive weeks before Day 1 - Must agree to maintain a stable diet from the first Screening Visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit - Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose |
Exclude criteria | - Ascites requiring treatment or symptomatic ascites - History of inflammatory bowel disease, achalasia or esophageal surgery - Has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA) |
Related Information
Primary Sponsor | Inoue Tomoyoshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05214768 |
Contact
Public contact | |
Name | Tomoyoshi Inoue |
Address | 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-120-093-507 |
MG-JP-RCO-JRCT@bms.com | |
Affiliation | Bristol-Myers Squibb |
Scientific contact | |
Name | Tomoyoshi Inoue |
Address | 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-120-093-507 |
mg-jp-clinical_trial@bms.com | |
Affiliation | Bristol-Myers Squibb |