Ein grossangelegter kontrollierter Klinischer Versuch für Patienten mit mittelschwerem bis schwerem aktiven Morbus Crohn um das Medikament Mirikizumab auf Wirksamkeit und Sicherheit zu bewerten.

Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MIRIKIZUMAB
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: MIRIKIZUMAB
Product Code: LY3074828
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Mirikizumab
CAS Number: 1884201-71-1
Current Sponsor code: LY3074828
Other descriptive name: MIRIKIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: STELARA 130 mg concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: MIRIKIZUMAB
Product

Gender:
Female: yes
Male: yes

Inclusion criteria:
? Diagnosis of CD for at least 3 months prior to baseline
? Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
? Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
? If female, subject must meet the contraception recommendations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1045
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion criteria:
? Currently have or are suspected to have an abscess. Recent cutaneous
and perianal abscesses are not exclusionary if drained, adequately
treated and resolved at least 3 weeks prior to baseline or 8 weeks prior
to baseline for intra-abdominal abscesses, provided that there is no
anticipated need for any further surgery.
? Have a stoma, ileoanal pouch or ostomy.
? Have had a bowel resection within 6 months, or any kind of intraabdominal
or extra abdominal surgery within 3 months of baseline.
? Have ever received anti-IL23p19 Antibodies.