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Crohn's DiseasePhase 1/2NCT02465944

A Pilot Study of FFP104 in Subjects With Crohn's Disease

A Phase 1/2 study testing FFP104 in people with Crohn's Disease, run by Fast Forward Pharmaceuticals at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will be conducted to evaluate the safety, tolerability and efficacy of intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with moderate to severely active Crohn's Disease Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
FFP104
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
2 sitesin 2 countries
Study dates
Jan 2016to Dec 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be entered into this study only if they meet all of the following criteria:
  • Willing and able to provide written informed consent.
  • Willing and able to comply with all study procedures and visits.
  • Male or female aged between 18 and 75 years, inclusive.
  • Body Mass Index (BMI) between 18-35 kg/m2.
  • Clinical diagnosis of Crohn's disease involving the colon and/or ileum for at least 3 months from Screening confirmed by radiological, endoscopic or histological evidence.
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  • Active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score from 220 and 450, inclusive, at Screening.
  • Active inflammatory disease as defined by Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8 (as determined by a Central Blinded Reader) at Screening.
  • Tumor Necrosis Factor (TNF)-naïve or previously exposed to a single anti-TNF agent (such as infliximab, adalimumab or certolizumab pegol) with treatment discontinued at least 8 weeks prior to Screening due to inadequate response, loss of response or intolerance as judged by the Investigator.
  • Must have adequate renal and hepatic function as adjudged by the Investigator.
  • In good health (other than Crohn's disease) as evidenced by medical history and physical examination.

Who cannot join

  • Subjects will be entered into this study only if they meet none of the following criteria:
  • Subjects who are pregnant, breastfeeding, or of child-bearing potential and not using a medically accepted form of contraception.
  • Presence of fistulas, ileostomies, colostomies or rectal pouches or history of proctocolectomy or total colectomy. Subject has an ostomy or ileoanal pouch (subjects with a previous ileorectal anastomosis are not excluded).
  • Subject has short bowel syndrome as determined by the Investigator.
  • History of evidence of colonic mucosal dysplasia.
  • Subject currently has a significant mechanical obstruction (stenosis).
Show all 37Show fewer
  • Subject has a current diagnosis of ulcerative or indeterminate colitis.
  • Immunization with a live vaccine within 4 weeks of Screening, with the exception of influenza vaccine and no planned immunizations within the period of the study.
  • Active or latent tuberculosis (TB) or tuberculosis infection; TB assessment and prophylaxis will be performed as per local biologicals regulations and guidelines.
  • Subjects with a history of or ongoing chronic or recurrent infectious disease within the 12 months prior to Screening.
  • Positive stool culture for Clostridium within the last 6 months prior to Screening.
  • Use of prohibited medications/procedures, including;
  • Concomitant corticosteroids doses exceeding 20 mg/day of prednisone (equivalent)
  • Concomitant use of budesonide
  • Concomitant use of anti-TNF therapy
  • Subjects who received previous treatment with more than one anti-TNF agent
  • Concomitant use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil
  • Prior or concomitant use of anti-α4 integrin or other non-TNF blocking biological
  • Use of tube or enteral feeding, elemental diet, or parenteral alimentation started within 2 weeks prior to Screening
  • Leukocytapheresis or granulocytapheresis within 2 weeks prior to Screening
  • Use of any prescription medications/products (with the exception of prescription medications for contraception and/or medications deemed acceptable by the Investigator and Sponsor).
  • Use of any over the counter (OTC), non-prescription preparations (including vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to the Check-in visit (Day 0), unless deemed acceptable by the Investigator and Sponsor.
  • Current or recent history (within 6 months of screening) of drug or substance abuse, including alcohol ≥ 14 units per week or who have a significant history of alcoholism or drug/chemical abuse within 6 months prior to the Screening visit (one unit of alcohol equals 0.5 pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1 shot [25 mL] of spirits).
  • Subjects with known clinically significant cardiac disease (e.g., myocardial infarction or stroke within 6 months prior to Screening, unstable angina, claudication, etc.), or evidence of a clinically significant electrocardiogram (ECG) abnormality at Screening.
  • A history of significant neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary or metabolic disease within 30 days of the Screening visit, as judged by the Investigator.
  • Have a family history (more than one first degree relative) of multiple thrombotic events or a personal history of any venous or arterial thrombotic event including deep vein thrombosis, stroke, myocardial infarction, pulmonary embolus, and peripheral arterial thromboembolic events.
  • Subject has had a positive hepatitis panel (including hepatitis B surface antigen [HBsAg], hepatitis B core antibody, and hepatitis C virus antibody [anti-HCV]) or a positive HIV antibody screen at time of Screening.
  • Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH) or abnormal hepatic markers (AST, ALT, ALP, or total bilirubin > 1.5 x upper limit of normal) at the time of the Screening visit.
  • Abnormal renal function (BUN or creatinine >1.25 x upper limit of normal) at the time of the Screening visit.
  • White Blood Cells <4 x 103/mm3; platelets <150 x 103/mm, hemoglobin < 6.2 mmol/L at the time of the Screening visit.
  • Subjects with evidence of other serious, significant, acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
  • History of malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
  • Active acute infection requiring systemic treatment for more than 2 weeks.
  • Planned surgery during the study period or have undergone major surgery within the 3 months prior to the Screening visit.
  • Subjects who have received any investigational drug within 60 days or use of other experimental anti-CD therapies within the last 30 days prior to Screening visit.
  • Known sensitivity to any component of the study drug or previous sensitivity reaction or other clinically significant reaction to intravenous medications or biologic therapy.
  • Subjects who have previously received FFP104 or have been previously enrolled in this study.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site, 1 recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Gert van Assche, Prof. Dr., +32 16 34 42 25

    Recruiting

Other trials in Belgium

Netherlands1 site, 1 recruiting

  • Erasmus Medical Center

    Rotterdam, 3015CE

    Janneke van der Woude, Prof. Dr., +31 107040126

    Recruiting

Other trials in Netherlands

About this study

Official title: A Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects With Moderate to Severely Active Crohn's Disease

This study will be conducted to evaluate the safety, tolerability and efficacy of intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with moderate to severely active Crohn's Disease

Conditions
Crohn's Disease
Being tested
FFP104, Placebo
Keywords
inflammation
Medical subject headings
Crohn Disease, Inflammation

What participants receive

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

  • FFP104Drug

    Three intravenous infusions of FFP104 over 15 days (d0, d7 and d14)

  • PlaceboDrug

    Three intravenous infusions of 0.9% Saline over 15 days (d0, d7 and d14)

Study groups in NCT02465944
Study groupRoleWhat they receive
FFP104 - 2.5 mg/kgExperimentalFFP104
Receives: Drug: FFP104
FFP104 - 5.0 mg/kgExperimentalFFP104
Receives: Drug: FFP104
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Safety and tolerability will be assessed through clinical laboratory tests, vital signs, physical exams, and adverse event assessments

    Measured: Up to 84 days

Secondary outcomes (14)

  1. Proportion of subjects achieving clinical response (decrease of Crohn's Disease Activity Index (CDAI) score by ≥100 points from baseline)

    Measured: Days 0, 7, 14, 28, 42 and 84

  2. Proportion of subjects achieving clinical remission (attainment of absolute CDAI score of 150 points or less from baseline)

    Measured: Days 0, 7, 14, 28, 42 and 84

  3. Proportion of subjects achieving partial response (decrease of CDAI score by >70 points from baseline)

    Measured: Days 0, 7, 14, 28, 42 and 84

  4. Difference in CDAI score between FFP104 treated subjects and placebo subjects in each arm of the study

    Measured: Days 0, 7, 14, 28, 42 and 84

  5. Time to response (decrease in CDAI score by >100 points)

    Measured: Days 0, 7, 14, 28, 42 and 84

  6. Time to partial response (decrease of CDAI score by >70 points)

    Measured: Days 0, 7, 14, 28, 42 and 84

  7. Change from baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS)

    Measured: Day 42

  8. Change from baseline in gut tissue organisation (histology)

    Measured: Day 42

  9. Percent change from baseline in faecal calprotectin level

    Measured: Day 42

  10. Percent change from baseline in C-Reactive Protein (CRP) levels

    Measured: Day 7, 14, 28, 42 and 84

  11. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

    Measured: Day 42

  12. Change from baseline in health outcome measures

    Health outcome measures that will be used are Short Form 36 (SF36), the EuroQol EQ-5D-5L and the Work Productivity and Activity Impairment Questionnaire Crohn's Disease (WPAI-CD)

    Measured: Day 42

  13. To evaluate changes from baseline in serum FFP104 levels

    Measured: up to 84 days

  14. To evaluate changes in lymphocyte sub-populations in peripheral blood

    Measured: Day 0, 14 and 42

Timeline

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

  1. First posted9 Jun 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2017 (estimated)
  4. Study completionDec 2017 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465944
Sponsor's protocol ID
FFP104-002
Other IDs
2015-001678-17, 2015
Status last verified
Aug 2016
First submitted
18 May 2015
Last updated
24 Aug 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FFP104 in people with Crohn's Disease, run by Fast Forward Pharmaceuticals at 2 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 11 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Netherlands. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability will be assessed through clinical laboratory tests, vital signs, physical exams, and adverse event assessments (time frame: Up to 84 days). 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 NCT02465944.

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 24 Aug 2016.

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