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Crohn's DiseasePhase 2NCT03850509

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

A Phase 2 study testing OPS-2071 in people with Crohn's Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 31 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day [BID]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Crohn's Disease
What is being tested?
OPS-2071
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
31 sitesin 2 countries
Study dates
25 Feb 2020to 22 May 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants 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).
  • Participants 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.
  • Participants who are on stable Crohn's disease medications for at least 4 weeks.
  • Participants with a CDAI score between 180 and 450 points, inclusive.
  • Participants who are willing and able to follow the trial protocol and have signed informed consent.

Who cannot join

  • 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.
  • Participants 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.
  • Participants taking antithrombotic drugs.
  • Participants with symptomatic bowel stenosis, fistula, or stoma; or with more than 2 bowel resections.
Show all 24Show fewer
  • Participants with short bowel syndrome.
  • participants with known existing aortic aneurysm, or who are at risk for an aortic aneurysm, such as participants with peripheral atherosclerotic vascular diseases, uncontrolled hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly participants (over the age of 70).
  • Participants with known or suspected (family history, unexplained syncope) long QT syndrome or QTcF > 470 msec for females or > 450 msec for males at baseline.
  • Participants 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.
  • Participants 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).
  • Participants with a history of treatment failure with 2 or more biologics.
  • Participants 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.
  • Participants with systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg.
  • Participants taking quinidine, procainamide, disopyramide, encainide, flecainide, sotalol, amiodarone, ibutilide, dronedarone, or propafenone.

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

United States24 sites

  • United States, Texas

    Austin, Texas, 78704

  • United States, Maryland

    Chevy Chase, Maryland, 20815

  • United States, Ohio

    Cincinnati, Ohio, 45219

  • United States, Florida

    Clearwater, Florida, 33756

  • United States, Colorado

    Colorado Springs, Colorado, 80907

  • United States, Ohio

    Dayton, Ohio, 45417

  • United States, Georgia

    Decatur, Georgia, 30033

  • United States, Georgia

    Doraville, Georgia, 30362

  • United States, North Carolina

    Greenville, North Carolina, 27834

  • United States, Texas

    Harlingen, Texas, 78550

  • United States, Florida

    Hialeah, Florida, 33012

  • United States, Florida

    Kissimmee, Florida, 34759

  • United States, California

    Los Angeles, California, 90067

  • United States, Virginia

    Lynchburg, Virginia, 24502

  • United States, Florida

    Naples, Florida, 34102

  • United States, Oklahoma

    Oklahoma City, Oklahoma, 73112

  • United States, Florida

    Orlando, Florida, 32825

  • United States, Florida

    Plantation, Florida, 33322

  • United States, South Carolina

    Rock Hill, South Carolina, 29732

  • United States, Texas

    San Antonio, Texas, 78229

  • United States, California

    San Carlos, California, 94070

  • United States, Kansas

    Shawnee Mission, Kansas, 66226

  • United States, Texas

    Sugar Land, Texas, 77479

  • United States, Texas

    Tyler, Texas, 75701

Other trials in United States

Poland7 sites

  • Poland

    Knurów, 44-190

  • Poland

    Lodz, 90-349

  • Poland

    Lodz, 90-572

  • Poland

    Oświęcim, 32-600

  • Poland

    Poznan, 60-369

  • Poland

    Poznan, 60-529

  • Poland

    Rzeszów, 35-326

Other trials in Poland

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment

The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day [BID]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.

Read the 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.

Conditions
Crohn's Disease
Being tested
OPS-2071, Placebo
Keywords
Crohn's disease, Inflammatory bowel disease, Fluoroquinolones, Inflammation, Intestine, Digestive tract, Abdominal pain, Diarrhea
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases, Inflammation, Abdominal Pain, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPS-2071Drug

    OPS-2071 300 mg, tablets, orally, BID.

  • PlaceboDrug

    OPS-2071-matched placebo, tablets, orally, BID.

Study groups in NCT03850509
Study groupRoleWhat they receive
OPS-2071 150 mg BIDExperimentalParticipants were to receive OPS-2071 150 mg, tablets, orally, twice daily (BID) in the morning and evening (8 to 12 hours apart) with 240 milliliters (mL) of water for up to 12 weeks.
Receives: Drug: OPS-2071
OPS-2071 300 mg BIDExperimentalParticipants received OPS-2071 300 mg, tablets, orally, BID in the morning and evening (8 to 12 hours apart) with 240 mL of water for up to 6 weeks.
Receives: Drug: OPS-2071
OPS-2071 600 mg BIDExperimentalParticipants were to receive OPS-2071 600 mg, tablets, orally, BID in the morning and evening (8 to 12 hours apart) with 240 mL of water for up to 12 weeks.
Receives: Drug: OPS-2071
PlaceboPlacebo comparatorParticipants received OPS-2071-matched placebo, tablets, orally, BID in morning and evening (8 to 12 hours apart) with 240 mL of water for up to 4 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score

    Clinical remission was defined as CDAI score <150 at Week 12. The CDAI evaluated severity of signs and symptoms of Chron's Disease. Some components of the CDAI were reported by the investigator (physical examination for the presence of an abdominal mass and extraintestinal complications, laboratory results for hematocrit levels, and weight) while other components were determined with data collected in a participant diary (number of liquid or soft stools, number of antidiarrheal medications, abdominal pain score, and general well-being). The index values of 150 and below were associated with quiescent disease; values above that indicated active disease, values >=220 indicated moderate to severe disease, and values above 450 were seen with extremely severe disease.

    Measured: Week 12

Secondary outcomes (7)

  1. Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD)

    Endoscopic response was defined as a reduction of the SES-CD by at least 50%, at Week 12. The SES-CD is a total score that indicates endoscopic disease activity status based on endoscopy results regarding the size of ulcers, surface ulceration, affected surface size, and presence of luminal narrowing. Each item is scored from 0-3, with total score from 0-60 . Higher score indicates more severe endoscopic activity.

    Measured: Week 12

  2. Change From Baseline in the SES-CD Score at Week 12

    The SES-CD is a total score that indicates endoscopic disease activity status based on endoscopy results regarding the size of ulcers, surface ulceration, affected surface size, and presence of luminal narrowing. Each item is scored from 0-3, with a total score from 0-60. A higher score indicates more severe endoscopic activity. A negative change from baseline indicates improvement.

    Measured: Baseline (Day 1) and Week 12

  3. Percentage of Participants With Two-item Participant Reported Outcome (PRO-2) Remission

    PRO-2 remission was defined as stool frequency =< 3 times per day and abdominal pain =< 1 at Week 12. The PRO-2 is a symptom control measure based on 2 participant-reported components (stool frequency and abdominal pain) of the CDAI (on an 11-point scale where 0=no pain to 10=worst imaginable pain). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.

    Measured: Week 12

  4. Percentage of Participants With Clinical Response Based on CDAI Score

    Clinical response was defined as at least a 25% decrease in the CDAI score at Week 12. The CDAI evaluated the severity of signs and symptoms of Chron's Disease. Some components of the CDAI were reported by the investigator (physical examination for the presence of an abdominal mass and extraintestinal complications, laboratory results for hematocrit levels, and weight) while other components were determined with data collected in a participant diary (number of liquid or soft stools, number of antidiarrheal medications, abdominal pain score, and general well-being). The index values of 150 and below were associated with quiescent disease; values above that indicated active disease, values >=220 indicated moderate to severe disease, and values above 450 were seen with extremely severe disease.

    Measured: Week 12

  5. Percentage of Participants With Endoscopic Remission Based on SES-CD

    Endoscopic remission was defined as an SES-CD total score of 0 to 2; or a score of 0 to 4, with no individual subscore greater than 1 at Week 12. The SES-CD is a total score that indicates endoscopic disease activity status based on endoscopy results regarding the size of ulcers, surface ulceration, affected surface size, and presence of luminal narrowing. Each item is scored from 0-3, with a total score from 0-60. A higher score indicates more severe endoscopic activity.

    Measured: Week 12

  6. Percentage of Participants With a Decrease in the CDAI Score at Week 12

    Percentage of participants who had a decrease of at least => 100 points in CDAI scores were to be reported. The CDAI evaluated the severity of signs and symptoms of Chron's Disease. Some components of the CDAI were reported by the investigator (physical examination for the presence of an abdominal mass and extraintestinal complications, laboratory results for hematocrit levels, and weight) while other components were determined with data collected in a participant diary (number of liquid or soft stools, number of antidiarrheal medications, abdominal pain score, and general well-being). The index values of 150 and below were associated with quiescent disease; values above that indicated active disease, values >=220 indicated moderate to severe disease, and values above 450 were seen with extremely severe disease.

    Measured: Week 12

  7. Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant and that does not necessarily have a causal relationship with the treatment. An SAE is defined as any fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention. A TEAE is defined as an AE that occurred after the administration of investigational medicinal product (IMP).

    Measured: From the signing of the informed consent form up to early termination (up to approximately 9 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2019
  2. Study start25 Feb 2020
  3. Primary completion22 May 2020
  4. Study completion22 May 2020

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850509
Sponsor's protocol ID
341-201-00004
Other IDs
2019-000176-41, 2019
Status last verified
May 2021
First submitted
15 Feb 2019
Last updated
15 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPS-2071 in people with Crohn's Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850509.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.

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