Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Brief Summary: The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.


Options:
A: Inclusion Criteria:

* Female or male aged ≥ 18 and ≤ 65 years
* Diagnosis of Crohn's Disease

Exclusion Criteria:

* Having ileostomy or pouch and/or colostomy
* Having previous gastric surgery
* Having a known or suspected systemic infection
B: Inclusion Criteria:

* Signed informed consent,
* Age 18 to 75 years,
* Symptoms of Crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria \[endoscopy not older than 12 months or if older, then clinical signs (e.g., pain localisation, pain intensity, blood in stool) and behaviour (according to Montreal classification) should be unchanged compared to former episodes\],
* Localisation of CD either in terminal ileum, coecum, ascending colon, or ileocolitis,
* Active phase of disease (200 \< CDAI \< 400),
* Negative pregnancy test in females of childbearing potential,
* Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

Exclusion Criteria:

* Known Crohn's lesions in the upper GI-tract (up to and including the jejunum) or rectum with present symptoms,
* Septic complications,
* Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
* Abscess, perforation, or active fistulas,
* Ileostomy or colostomy,
* Resection of more than 50 cm of the ileum,
* Bowel surgery within the last 3 months,
* Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
* Clinical signs of stricturing disease,
* Subileus within the last 6 months (subileus with inflammatory hint allowed),
* Suspicion of ileus, subileus or corresponding symptoms,
* Parenteral or tube feeding,
* Active peptic ulcer disease, local intestinal infection, or known established cataract,
* Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or hypertension if careful medical monitoring is not ensured,
* Abnormal hepatic function (ALT or ALP \> 2.5 x upper limit of normal \[ULN\]), liver cirrhosis, or portal hypertension,
* Abnormal renal function (Cystatin C \> ULN),
* Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
* History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma),
* Treatment with immunosuppressants or anti-cancer drugs, e.g., 6 TG, methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6 MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study,
* Treatment with ketoconazole or other CYP3A inhibitors within the last month before baseline visit,
* Treatment with anti-TNF-alpha therapy within 3 months before baseline visit,
* Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit,
* \> 6 mg/d budesonide po within 2 weeks before baseline visit,
* Steroids for inhalation within 2 weeks before baseline visit,
* Patients known to be steroid-refractory,
* Treatment of study disease with oral antibiotics (e.g., metronidazole or ciprofloxacin) within the last 2 weeks,
* Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit except ≤ 350 mg/d or short-term acetylsalicylic acid (paracetamol is allowed),
* Known intolerance/hypersensitivity to study drug,
* Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs,
* Existing or intended pregnancy or breast-feeding,
* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
C: Inclusion Criteria:

1. Age 18 to 80
2. Diagnosis of moderately to severely active Crohn's disease (CD)
3. CD involvement of the ileum and/or colon
4. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents, within protocol-specified parameters:

   1. Immunomodulators
   2. Tumor necrosis factor-alpha (TNFα) antagonists
   3. Corticosteroids
5. May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol

Exclusion Criteria

1. Evidence of abdominal abscess at the initial screening visit, other than a minimum of 10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine
2. Extensive colonic resection, subtotal or total colectomy
3. History of \>3 small bowel resections or diagnosis of short bowel syndrome
4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
5. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
6. Chronic hepatitis B or C infection
7. Active or latent tuberculosis
D: Inclusion Criteria:

* Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3\*. \*Vienna Classification (1998)
* Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.
* Male and female aged 18 years or above at screening.
* Patients who meet all concomitant medication criteria in the protocol specified table. For all drugs being taken at screening, the patient should be able to remain on a stable dose throughout the duration of the study, although steroids may be tapered starting at Weeks 8 to 12.

Exclusion Criteria:

* Crohn's Disease Related
* Fistula abscess present at screening.
* Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
* Short bowel syndrome.
* Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
* Positive stool laboratory results for enteric pathogens.

Answer: A