A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment

Conditions

Crohn`s Disease (CD)

Brief summary

Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at week 12.

Detailed description

Percent change in SES-CD from baseline at Week 12-, Endoscopic response (defined as ≥50% SES-CD reduction from baseline) or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12, Endoscopic response (defined as ≥50% SES-CD reduction from baseline), or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 48, Endoscopic remission (defined as SES-CD score of ≤2) at week 12, Endoscopic remission (defined as SES-CD score of ≤2) at week 48, Biological remission, defined as C-reactive protein (CRP) <5 mg/L and faecal calprotectin (FCP) < 250 ug/g at week 12, Biological remission, defined as CRP < 5 mg/L and FCP <250 ug/g at week 48, Clinical remission at week 12, defined as a Crohn's Disease Activity Index (CDAI) score of <150, Clinical remission at week 48, defined as a CDAI score of<150, Clinical response at week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI score of <150, Number of patients with treatment-emergent adverse event (TEAE) through end of treatment (EoT) and the residual effect period (REP) (i.e. through Visit 9)

Related papers

No related papers found yet.

Interventions

DRUGMatching placebo tablets without active substance

DRUGBI 706321

DRUGSTELARA 130 mg concentrate for solution for infusion

DRUGSTELARA 90 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at week 12.	—

Secondary

Measure	Time frame
Percent change in SES-CD from baseline at Week 12-, Endoscopic response (defined as ≥50% SES-CD reduction from baseline) or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12, Endoscopic response (defined as ≥50% SES-CD reduction from baseline), or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 48, Endoscopic remission (defined as SES-CD score of ≤2) at week 12, Endoscopic remission (defined as SES-CD score of ≤2) at week 48, Biological remission, defined as C-reactive protein (CRP) <5 mg/L and faecal calprotectin (FCP) < 250 ug/g at week 12, Biological remission, defined as CRP < 5 mg/L and FCP <250 ug/g at week 48, Clinical remission at week 12, defined as a Crohn's Disease Activity Index (CDAI) score of <150, Clinical remission at week 48, defined as a CDAI score of<150, Clinical response at week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI scor	—

Measure

Time frame

Percent change in SES-CD from baseline at Week 12-, Endoscopic response (defined as ≥50% SES-CD reduction from baseline) or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12, Endoscopic response (defined as ≥50% SES-CD reduction from baseline), or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 48, Endoscopic remission (defined as SES-CD score of ≤2) at week 12, Endoscopic remission (defined as SES-CD score of ≤2) at week 48, Biological remission, defined as C-reactive protein (CRP) <5 mg/L and faecal calprotectin (FCP) < 250 ug/g at week 12, Biological remission, defined as CRP < 5 mg/L and FCP <250 ug/g at week 48, Clinical remission at week 12, defined as a Crohn's Disease Activity Index (CDAI) score of <150, Clinical remission at week 48, defined as a CDAI score of<150, Clinical response at week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI scor

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Countries

Czechia, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed