Crohn’s disease MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: NNC0142-0000-0002
Product Code: NNC142-0002
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: N/A
Current Sponsor code: NNC142-0002
Concentration unit: mg/ml mi
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women (not pregnant and not nursing) of =18 and =75 years of age - Subjects with CD for at least 3 months having active disease with a CDAI score of =220 and =450 and evidence of inflammation confirmed by a C-reactive protein (CRP) level =10 mg/L (or =1.0 mg/dL) or endoscopic verification - Biologic-naïve subjects or biologic-experienced for the treatment of CD having discontinued due to lack of efficacy to only one biologic therapy (primary or secondary failure), intolerance to therapy, or other reasons (e.g. drug holiday). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess • History of dysplasia or malignancy in the colon • Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation • Body mass index (BMI) =38.0 kg/m^2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare disease activity following a single s.c. dose of NNC142-0002 to placebo in subjects with moderately to severely active CD, measured 4 weeks after administration.;Secondary Objective: • To compare safety and tolerability of NNC142-0002 and placebo • To compare change in disease activity at other time-points than Week 4, clinical response and remission, between subjects treated with NNC142-0002 and subjects receiving placebo • To compare the quality of life (QoL) between subjects treated with NNC142-0002 and subjects receiving placebo • To compare use of concomitant medication for CD between subjects treated with NNC142-0002 and subjects receiving placebo • To describe the pharmacokinetics (PK) of NNC142-0002 during treatment • To compare the pharmacodynamics (PD) response, by assessment of various biomarkers, between subjects treated with NNC142-0002 and subjects receiving placebo • To describe the immunogenicity of NNC142-0002;Primary end point(s): The primary endpoint is change in disease activity assessed by the Crohn’s disease activity index (CDAI) from baseline to Week 4.;Timepoint(s) of evaluation of this end point: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Number and frequency of adverse events (AEs) from baseline to Weeks 12 and 24 b) Immunogenecity of NNC142-0002 at week 24;Timepoint(s) of evaluation of this end point: a) Week 12 and 24 b) Week 24 | — |
Countries
Belgium, Canada, European Union, Hungary, Israel, Poland, Russian Federation, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed