A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients with Moderate to Severe Crohn’s Disease (AMALTHEA)

Conditions

Crohn's Disease

Brief summary

CDAI remission (CDAI score < 150)

Detailed description

Endoscopic response (> 50% decrease from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score). Participants who meet definition of endoscopic remission will be considered to also have met endoscopic response., Endoscopic remission *SES-CD total score ≤ 2 OR *SES-CD total score ≤ 4 (≤ 2 with ileal/ileocecal disease) and at least 2-point decrease from baseline with no individual subscore > 1, Endoscopic score change from baseline, CDAI response (≥ 100 points decrease from the baseline CDAI or CDAI score < 150 points), CDAI score change from baseline, Symptomatic remission (average daily stool frequency ≤ 2.8 AND average daily abdominal pain ≤ 1, and neither worse than baseline), Serum AZD7798 concentration and incidence and titre of anti-drug antibody (ADA) response

Related papers

No related papers found yet.

Interventions

DRUGAZD7798

DRUGAZD7798 Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Endoscopic response (> 50% decrease from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score). Participants who meet definition of endoscopic remission will be considered to also have met endoscopic response., Endoscopic remission SES-CD total score ≤ 2 OR SES-CD total score ≤ 4 (≤ 2 with ileal/ileocecal disease) and at least 2-point decrease from baseline with no individual subscore > 1, Endoscopic score change from baseline, CDAI response (≥ 100 points decrease from the baseline CDAI or CDAI score < 150 points), CDAI score change from baseline, Symptomatic remission (average daily stool frequency ≤ 2.8 AND average daily abdominal pain ≤ 1, and neither worse than baseline), Serum AZD7798 concentration and incidence and titre of anti-drug antibody (ADA) response	—

Measure

Time frame

Endoscopic response (> 50% decrease from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score). Participants who meet definition of endoscopic remission will be considered to also have met endoscopic response., Endoscopic remission *SES-CD total score ≤ 2 OR *SES-CD total score ≤ 4 (≤ 2 with ileal/ileocecal disease) and at least 2-point decrease from baseline with no individual subscore > 1, Endoscopic score change from baseline, CDAI response (≥ 100 points decrease from the baseline CDAI or CDAI score < 150 points), CDAI score change from baseline, Symptomatic remission (average daily stool frequency ≤ 2.8 AND average daily abdominal pain ≤ 1, and neither worse than baseline), Serum AZD7798 concentration and incidence and titre of anti-drug antibody (ADA) response

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Primary

Measure	Time frame
CDAI remission (CDAI score < 150)	—

Countries

Austria, Belgium, Bulgaria, Croatia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed