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
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 (CC-93538-EG-001)
Inoue Tomoyoshi
Bristol-Myers Squibb
1-2-1 Otemachi, Chiyoda-ku, Tokyo
+81-120-093-507
mg-jp-clinical_trial@bms.com
Inoue Tomoyoshi
Bristol-Myers Squibb
1-2-1 Otemachi, Chiyoda-ku, Tokyo
+81-120-093-507
MG-JP-RCO-JRCT@bms.com
Complete
Mar. 07, 2022
Mar. 04, 2022
45
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
- 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
- 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)
12age old over
75age old under
Both
Eosinophilic gastroenteritis
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.
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]
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]
