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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 February 2021
Main ID:  NCT03850509
Date of registration: 15/02/2019
Prospective Registration: Yes
Primary sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Public title: Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation
Scientific title: Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment
Date of first enrolment: February 25, 2020
Target sample size: 3
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT03850509
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Poland United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects between the ages of 18 and 70 years, inclusive

- Diagnosis of Crohn's disease localized in the ileum and/or colon, with active mucosal
inflammation and visible lesion(s), documented by centrally read ileocolonoscopy and a
Simple Endoscopic Score for Crohn's Disease (SES-CD) = 6 (= 4 for isolated ileal
disease).

- Subjects who do not have an optimal response (daily stool frequency > 3 and pain score
> 1) to their current ongoing treatment of biologics (eg, first anti-tumor necrosis
factor-alpha [TNF-a] monoclonal antibody), immunosuppressants, low-dose steroids, or
5-aminosalicylic acid (5-ASA) formulations.

- Subjects who are on stable Crohn's disease medications for at least 4 weeks.

- Subjects with a CDAI score between 180 and 450 points, inclusive.

- Subjects who are willing and able to follow the trial protocol and have signed
informed consent.

Exclusion Criteria:

- Females who are breast-feeding and/or who have a positive pregnancy test result prior
to receiving IMP.

- Sexually active males or WOCBP who do not agree to practice 2 different methods of
birth control or remain abstinent during the trial and for 30 days after the last dose
of IMP. If employing birth control, 2 of the following precautions must be used:
vasectomy, tubal ligation, intrauterine device, birth control pill, birth control
implant, or birth control depot injection. A vaginal diaphragm, condom with
spermicide, or sponge with spermicide may also be used as measures to prevent
pregnancy, but must be used in combination with at least one of the previous methods.

- Subjects taking any nonsteroidal anti-inflammatory drugs that cannot be stopped or
replaced.

- Use of prednisone or prednisolone > 30 mg/day or budesonide > 9 mg/day within 4 weeks
prior to screening; or intravenous steroids within 4 weeks prior to screening.

- Subjects taking antithrombotic drugs.

- Subjects with symptomatic bowel stenosis, fistula, or stoma; or with more than 2 bowel
resections.

- Subjects with short bowel syndrome.

- Subjects with known existing aortic aneurysm, or who are at risk for an aortic
aneurysm, such as subjects with peripheral atherosclerotic vascular diseases,
uncontrolled hypertension, certain genetic conditions such as Marfan syndrome and
Ehlers-Danlos syndrome, and elderly subjects (over the age of 70).

- Subjects with known or suspected (family history, unexplained syncope) long QT
syndrome or QTcF > 470 msec for females or > 450 msec for males at baseline.

- Subjects with inadequate organ function, as follows:

- Serum creatinine > 1.5x the upper limit of normal (ULN)

- Aspartate aminotransferase or alanine aminotransferase levels > 1.5x ULN

- Total bilirubin > 1.5x ULN. Elevated unconjugated bilirubin related to Gilbert's
syndrome is allowed.

- Use of antibiotics (eg. metronidazole, rifaximin, tinidazole, ciprofloxacin,
clarithromycin) within 15 days prior to screening or for greater than 2 months within
the past year. A short course (maximum of 5 days) of antibiotics will be permitted
during the trial, as needed, for indications other than Crohn's disease.

- Known hypersensitivity to quinolones or other significant adverse reaction to
quinolones.

- Conditions or circumstances that could prevent completion of the trial according to
the judgment of the investigator, including an uncontrolled comorbidity, heart
condition, or dysfunction of any other organ; peripheral neuropathy; known
arrhythmias, atrial fibrillation, or paroxysmal tachycardia; history of myasthenia
gravis; history of drug or alcohol abuse, mental illness, or noncompliance with
treatments or visits; or known immune-deficiency.

- HIV infection, viral hepatitis, prior organ transplant, or malignant disease that is
not in remission for at least 3 years, with the exception of basal cell carcinoma.

- Subjects who have used any investigational drug within 2 months prior to screening.

- Blood donation in the last 2 months.

- Use of inhibitors of UGT1A1 and UGT1A9 (eg, Silybin, diclofenac, mycophenolic acid,
efavirenz, regorafenib) and BCRP (eg, Estrone, 17ß-estradiol, flavonoids, herb
extracts, gefitinib, imatinib, tamoxifen, novobiocin, nelfinavir, ritonavir,
dipyridamole, fumitremorgin C, Ko143, cyclosporine, curcumin, eltrombopag, omeprazole,
ivermectin).

- Subjects with a history of treatment failure with 2 or more biologics.

- Subjects with risk factors for tendon rupture (ie, psoriasis, ankylosing spondylitis,
competitive athletes, renal failure, diabetes mellitus) or who have a history of
tendon rupture and/or ongoing tendinopathy.

- Subjects with systolic blood pressure > 150 mmHg or diastolic blood pressure > 90
mmHg.

- Subjects taking quinidine, procainamide, disopyramide, encainide, flecainide, sotalol,
amiodarone, ibutilide, dronedarone, or propafenone.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: OPS-2071 300 mg
Drug: OPS-2071 600 mg
Drug: Matching Placebo
Drug: OPS-2071 150 mg
Primary Outcome(s)
The percentage of subjects with Crohn's Disease on treatment with active symptoms who have achieved clinical remission at Week 12 using the Chron's Disease Activity Index (CDAI) score [Time Frame: From enrollment to end of treatment at 12 weeks]
Secondary Outcome(s)
The percentage of subjects with Crohn's Disease on treatment with active symptoms who have a decrease in the Crohn's Disease Activity Index (CDAI) score from baseline up to Week 12 [Time Frame: From enrollment to end of treatment at 12 weeks]
The number of subjects with Crohn's Disease on treatment with active symptoms who have had a change from baseline up to Week 12 in the Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time Frame: From enrollment to end of treatment at 12 weeks]
The percentage of subjects with Crohn's Disease on treatment with active symptoms who have achieved a clinical response at Week 12 using the Crohn's Disease Activity Index (CDAI) score [Time Frame: From enrollment to end of treatment at 12 weeks]
The percentage of subjects with Crohn's Disease on treatment with active symptoms who have achieved an endoscopic response at Week 12 using the Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time Frame: From enrollment to end of treatment at 12 weeks]
The percentage of subjects with Crohn's Disease on treatment with active symptoms who have achieved endoscopic remission at Week 12 using the Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time Frame: From enrollment to end of treatment at 12 weeks]
The percentage of subjects with Crohn's Disease on treatment with active symptoms who have achieved remission at Week 12 using the PRO-2 [Time Frame: From enrollment to end of treatment at 12 weeks]
Secondary ID(s)
341-201-00004
2019-000176-41
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Iqvia Pty Ltd
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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