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Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03850509
Recruitment Status : Terminated (Sponsor Decision)
First Posted : February 21, 2019
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description
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Brief Summary:
The purpose of this study is the effects, safety and how OPS-2071 (150, 300, or 600 mg twice a day [BID]) is as an add-on therapy in Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: OPS-2071 150 mg Drug: OPS-2071 300 mg Drug: OPS-2071 600 mg Drug: Matching Placebo Phase 2

Detailed Description:
OPS-2071 is a novel agent that is currently being developed for the treatment of Crohn's disease and was previously investigated for the treatment of enteric infection, including those caused by Clostridium difficile. OPS-2071 belongs to the fluoroquinolone family of compounds and has shown anti-inflammatory and potent antibacterial activity in in vitro and in vivo assays. OPS-2071 is anticipated to be effective in the treatment of Crohn's disease due to its unique mode of action. In vitro investigations of OPS-2071 showed a dual mechanism of action, including a potent, broad spectrum antibacterial effect and a strong anti-inflammatory effect that translated into significant attenuation of numerous cytokines, including TNF-alpha (TNF-α) Screening.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Double (Participant, Investigator)
Masking Description: two or more parties are unaware of the intervention assignment
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment
Actual Study Start Date : February 25, 2020
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: OPS-2071 150 mg
150 mg BID Oral for 12 weeks
 Drug: OPS-2071 150 mg
150 mg BID Oral for 12 weeks,
Experimental: OPS-2071 300 mg
300mg BID Oral for 12 weeks
 Drug: OPS-2071 300 mg
300 mg BID Oral for 12 weeks
Experimental: OPS-2071 600 mg
600 mg BID Oral for 12 weeks
 Drug: OPS-2071 600 mg
600 mg BID Oral for 12 weeks
Experimental: Matching placebo
Matching placebo BID Oral for 12 weeks
 Drug: Matching Placebo
Matching Placebo BID Oral for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    The percentage of subjects with Crohn's Disease on treatment with active symptoms that have a CDAI score <150 at Week 12


Secondary Outcome Measures :
  1. 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 with a reduction of the SES-CD score by at least 50 percent

  2. 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 number of subjects with Crohn's Disease on treatment with active symptoms with a change in the SES-CD score from baseline

  3. 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 ]
    The percentage of subjects with Crohn's Disease on treatment with active symptoms that have a PRO-2 remission defined as a stool frequency ≤ 3 times per day and abdominal pain ≤ 1

  4. 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 that have at least a 25 percent decrease in the CDAI score

  5. 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 that have a SES-CD score of 0 to 2; or a score of 0 to 4, with no individual subscore greater than 1

  6. 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 percentage of subjects with Crohn's Disease on treatment with active symptoms that have a decrease of ≥ 100 points in the CDAI score


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-α] 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, 17β-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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850509


Locations
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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Iqvia Pty Ltd
More Information
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03850509    
Other Study ID Numbers: 341-201-00004
2019-000176-41 ( EudraCT Number )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Crohn's Disease
inflammatory bowel disease
fluoroquinolones
inflammation
 intestine
digestive tract
abdominal pain
diarrhea
Additional relevant MeSH terms:
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Crohn Disease
Inflammation
Pathologic Processes
Inflammatory Bowel Diseases
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases