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Inflammatory Bowel DiseasesPhase 2NCT03139032

Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations

A Phase 2 study testing APD334 in people with Inflammatory Bowel Diseases and Skin Extra-intestinal Manifestations, run by Arena Pharmaceuticals at 3 sites in 3 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 phase 2a, proof of concept, open-label clinical study is to evaluate the efficacy and safety of etrasimod (APD334) in inflammatory bowel disease patients with active skin extra-intestinal manifestations. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
APD334
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
3 sitesin 3 countries
Study dates
17 Jul 2017to 6 Dec 2017
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female (18-80 years).
  • Able to provide a signed informed consent prior to any study related procedure being conducted.
  • Considered to be in stable health in the opinion of the investigator as determined by:
  • A pre-study physical examination with no clinically significant abnormalities unrelated to IBD.
  • Vital signs at screening: pulse rate ≥ 55 bpm, systolic blood pressure ≥ 90, and diastolic blood pressure ≥ 55 mmHg.
  • Liver function tests (ALT/AST, bilirubin and alkaline phosphatase) < 2x the upper limit of normal.
Show all 15Show fewer
  • All other pre-study clinical laboratory findings within normal range, or if outside of the normal range are not deemed clinically significant in the opinion of the investigator.
  • 12-lead electrocardiogram showing no clinically significant abnormalities in the opinion of the investigator (for confirmation please refer to exclusion criterion # 22).
  • A chest x- ray showing no evidence of active pulmonary disease (a chest x-ray taken within the previous 12 months from the screening visit may also be used).
  • Ophthalmology evaluation (by an ophthalmologist) without evidence of macular edema, supported with optical coherence tomography where available (dependent on site capability) no later than 3 months prior to screening.
  • Patients receiving stable treatment for IBD and EIM.
  • Diagnosis of active psoriasis, erythema nodosum or pyoderma gangrenosum by Investigator assessments. After the enrollment of 10 patients with active EIM, patients with active psoriasis due to anti TNF-alpha therapy can also be included.
  • Diagnosis of ulcerative colitis or Crohn's disease established prior to screening by clinical and endoscopic evidence.
  • Eligible male and female patients must agree not to participate in a conception process (i.e. active attempt to let female partner to become pregnant or to impregnate, sperm donation, oocyte donation, in vitro fertilization) for at least 30 days after the last dose of study drug.
  • Non-sterile patients who are sexually active must take adequate contraception measures.

Who cannot join

  • Evidence of abdominal abscess or toxic megacolon at the screening visit.
  • Patients with history of extensive colitis or pancolitis (duration > 8 years) or left-sided colitis (duration > 12 years) must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (if not, the patient should undergo a colonoscopy in lieu of a flexible proctosigmoidoscopy during screening).
  • Previous extensive colonic resection (subtotal or total colectomy).
  • Current evidence of adenomatous colonic polyps that have not been removed.
  • Current evidence of colonic mucosal dysplasia.
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine or stoma.
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  • Clinical significant infection as judged by the investigator in the previous 6 weeks before enrollment.
  • Evidence of or treatment for C. difficile infection within 60 days, or other intestinal pathogen within 30 days, prior to randomization.
  • Exposure to natalizumab or rituximab within 5 half-lives prior to randomization.
  • Treatment of underlying disease within 30 days prior to randomization (5-ASA, corticosteroids, TNF-alpha inhibitors, probiotics, antidiarrheals, azathioprine and 6-mercaptopurine may be allowed under certain conditions).
  • Receipt of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
  • Currently require or are anticipated to require surgical intervention for IBD during the study.
  • Abnormal (< 80% of predicted values) forced expiratory volume (FEV1) or forced vital capacity (FVC).
  • Infection with hepatitis C virus anytime in the past; confirmed active infection with hepatitis B virus at screening.
  • Active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
  • History of TB
  • A positive diagnostic TB test within one month of randomization
  • Chest X-ray within 12 months of randomization in which active or latent TB cannot be excluded.
  • Any known history of congenital or acquired immunodeficiency.
  • Clinically significant extra-intestinal infection (e.g., pneumonia, pyelonephritis) within 30 days prior to randomization.
  • Recent history (within 6 months of screening visit) of cardio- or cerebrovascular disease, acute coronary syndrome, myocardial infarction, unstable angina, cerebro-vascular accident, including transient ischemic attack.
  • Any surgical procedure requiring general anesthesia within 30 days prior to randomization or plans to undergo major surgery during the study period.
  • History of retinal macular edema.
  • History of or signs and symptoms of progressive multifocal leukoencephalopathy (PML) as assessed by the PML checklist.
  • History or presence of cardiac arrhythmia, conduction system disease, or use of Class Ia or Class III anti arrhythmic agents, or baseline QTc ≥ 500 msec.
  • Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 4 weeks of screening.
  • History of more than one episode of herpes zoster or any episode of disseminated zoster.
  • Without documented positive varicella zoster virus (VZV) IgG antibody status or who have completed VZV vaccination within 30 days prior to randomization.
  • Receipt of live vaccine within 4 weeks prior to screening.
  • History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma.
  • History of malignancy except for adequately treated basal cell skin cancer.
  • History of severe allergic or anaphylactic reactions requiring medical attention.
  • Current or recent history (within one year prior to randomization) of alcohol dependence or illicit drug use.
  • History of clinically significant leukopenia or lymphopenia at screening.
  • Active psychiatric problems that, in the investigator's opinion, may interfere with compliance with the study procedures.
  • History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study.
  • Use of moderate to strong inhibitors of CYP2C9.
  • History of severe renal or hepatic impairment.
  • Inability to attend all the study visits or comply with study procedures.
  • Prior exposure to etrasimod (APD334).

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Belgium1 site

  • Arena 2001

    Leuven

Other trials in Belgium

Germany1 site

  • Arena 1001

    Hamburg

Other trials in Germany

Serbia1 site

  • Arena 3001

    Belgrade

Other trials in Serbia

About this study

Official title: A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations

The purpose of this phase 2a, proof of concept, open-label clinical study is to evaluate the efficacy and safety of etrasimod (APD334) in inflammatory bowel disease patients with active skin extra-intestinal manifestations.

Being tested
APD334
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

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

  • APD334Drug

    Also called Etrasimod

    APD334 active treatment for 12 weeks.

Study groups in NCT03139032
Study groupRoleWhat they receive
APD334ExperimentalAPD334 active treatment for 12 weeks.
Receives: Drug: APD334

What is being measured

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

  1. Exploratory Endpoint - Change From Baseline in Endoscopic Improvement/Histologic Healing Using Endoscopy or Flexible Proctosigmoidoscopy

    Only if there are signs of inflammation at screening another evaluation was planned to be performed at week 12.

    Measured: Weeks 12

  2. Exploratory Endpoint - Change From Baseline in Level of Fecal Calprotectin

    Measured: Weeks 4, 8, and 12

  3. Exploratory Endpoint - Change From Baseline in Physician Global Assessments for Active Skin Extra-intestinal Manifestations (EIM) (PG, EN and Psoriasis)

    Measured: Weeks 1, 2, 4, 8, and 12

  4. Exploratory Endpoint - Change From Baseline in Patient Global Assessments for Active Skin EIM

    Measured: Weeks 1, 2, 4, 8, and 12

  5. Exploratory Endpoint - Change From Baseline in the Dermatology Life Quality Index Score

    Measured: Weeks 1, 2, 4, 8, and 12

  6. Exploratory Endpoint - Change From Baseline in Inflammatory Bowel Disease Questionnaire Score

    Measured: Weeks 2, 4, 8, and 12

  7. Exploratory Endpoint - Change From Baseline in C-reactive Protein

    Measured: Weeks 1, 2, 4, 8, 12 and the 2-week follow-up visit

  8. Exploratory Endpoint - Change From Baseline in Leucocyte Characterization

    Measured: Weeks 8 and 12

  9. Exploratory Endpoint - Change From Baseline in Stool Frequency at Ulcerative Colitis Endpoint

    Measured: Weeks 1, 2, 4, 8, and 12

  10. Exploratory Endpoint - Change From Baseline in Rectal Bleeding at Ulcerative Colitis Endpoint

    Measured: Weeks 1, 2, 4, 8, and 12

  11. Exploratory Endpoint - Change From Baseline in Physicians Global Assessments at Ulcerative Colitis Endpoint

    Measured: Weeks 1, 2, 4, 8, and 12

  12. Exploratory Endpoint - Change From Baseline in Lymphocyte Counts

    Measured: Weeks 1, 2, 4, 8, and 12

  13. Exploratory Endpoint - Change From Baseline in Disease Activity Score at Crohn's Disease Endpoint

    Measured: Weeks 1, 2, 4, 8, and 12

  14. Exploratory Endpoint - Change From Baseline in Psoriasis Area and Severity Index at Psoriasis Endpoint

    Measured: Weeks 1, 2, 4, 8, and 12

  15. Exploratory Endpoint - Changes in Degree of Immune Cell Infiltration as Assessed From Skin Punch Biopsies (From Healthy Skin and From Target Lesion)

    Measured: Weeks -1, 8, and 12.

  16. Exploratory Endpoint -Changes in Levels of Cytokine Expression as Assessed From Skin Punch Biopsies (From Healthy Skin and From Target Lesion)

    Measured: Weeks -1, 8 and 12.

Timeline

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

  1. First posted3 May 2017
  2. Study start17 Jul 2017
  3. Primary completion6 Dec 2017
  4. Study completion6 Dec 2017

Why it stopped: Sponsor decision to terminate the study

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
Not applicable
Intervention model
Single group
Model description
Proof of concept, open label
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139032
Sponsor's protocol ID
APD334-006
Status last verified
Dec 2020
First submitted
26 Apr 2017
Last updated
31 Dec 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APD334 in people with Inflammatory Bowel Diseases and Skin Extra-intestinal Manifestations, run by Arena Pharmaceuticals at 3 sites in 3 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 15 inclusion and 40 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, Germany, Serbia. 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. 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 31 Dec 2020). 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?

Exploratory Endpoint - Change From Baseline in Endoscopic Improvement/Histologic Healing Using Endoscopy or Flexible Proctosigmoidoscopy (time frame: Weeks 12). The study lists 16 primary outcomes in all. 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 NCT03139032.

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 31 Dec 2020.

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