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Ankylosing SpondylitisPhase 3NCT02685904

A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis

A Phase 3 study testing ENIA11 in people with Ankylosing Spondylitis, run by Mycenax Biotech Inc. at 6 sites in Taiwan.

Terminated

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

Official record
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Trial summary

This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in patients with ankylosing spondylitis. The study period for each patient will be 27 weeks, during which the patient will undergo screening for up to 21 days, and followed by… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
ENIA11
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
6 sitesTaiwan
Study dates
6 Sep 2016to 31 Dec 2018
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged ≥ 20 years old
  • Patients meet the Ankylosing Spondylitis criteria of modified New York (1984) for over 3 month duration
  • Patient with active disease at the time of screening as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≧4 and a spinal pain score ≧4 on a Numeric Rating Scale (NSR).
  • Presence of at least one of the following criteria:
  • Erythrocyte Sedimentation Rate (ESR) : male≧13 mm/hr ; female≧22 mm/hr
  • C-Reactive Protein (CRP) ≧ 0.5 mg/dl
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  • Patients have been treated optimal daily doses of at least two NSAIDs for at least 2 weeks, or documented intolerance to NSAIDs
  • Patient is willing and able to comply with study procedures and sign informed consent
  • Patient may be receiving stable dose of permitted DMARDs (methotrexate at max of 25 mg/week, sulfasalazine at max of 3 g/day) since at least 2 weeks prior screening visit.
  • Patient may be receiving stable dose of corticosteroids (eg. Prednisolone ≦10mg/day) since at least 2 weeks prior screening visit.
  • No evidence of active pulmonary tuberculosis (TB) as defined by the following:
  • A Chest X-ray taken at screening (unless it has been previously taken and documented within 3 months) was not active TB infection.
  • QuantiFERON-TB Gold Test negative
  • QuantiFERON-TB Gold Test for the Positive or indeterminate 2 times, patient need to perform more than four weeks before INH treatment enrolled to the trial and received an adequate course of therapy (eg, 9 months of INH treatment).
  • Patient has previously received an adequate course of therapy (eg, 9 months of INH treatment) for either latent or active TB infection.
  • No evidence of active hepatitis B as defined by the following:
  • HBsAg(-), HBcAb(-) or
  • HBsAg(-), HBcAb(+), HBV DNA undetected or
  • HBsAg(+), HBcAb(+), HBV DNA undetected or
  • HBsAg(+), HBcAb(+), HBV DNA <20000 IU, ALT was normal, AST was normal

Who cannot join

  • Known hypersensitivity to etanercept or ENIA11 or any of its components
  • Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a soluble TNF receptor (e.g., infliximab)
  • Suspected or diagnosed active pulmonary tuberculosis, or other chronic or current infectious disease at discretion of investigator
  • Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator
  • Patients with any of the following laboratory abnormalities: ALT/AST > 3 times ULN, creatinine > 2 mg/dl, WBC < 3,000/mm3, Hemoglobin < 8.5 g/dL, platelet count < 100,000/mm3 (6) Patients have received live attenuated vaccination program within 3 months or BCG vaccine within 12 months prior enrollment
  • Female patient of childbearing potential who:
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  • is lactating; or
  • has positive urine pregnancy test at Visit 1; or
  • refuse to adopt reliable method of contraception during the study;
  • Suspected or diagnosed active for human immunodeficiency, hepatitis B or hepatitis C virus (HCV Ab+ and HCV RNA+)
  • Patient has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product
  • Patient who receiving any prohibited concomitant medications as following,
  • Other DMARDs (Hydroxychloroquine, azathioprine, cyclosporine, D-penicillamine, cyclosprin, Gold) from 4 weeks prior first dose of the study drug.
  • Leflunomide from 8 weeks prior first dose of the study drug.
  • Other biologicals indicated for AS from 4 weeks prior first dose of the study drug.
  • Humira from 2 month prior first dose of the study drug.
  • Live attenuated vaccination program from 3 month prior first dose of the study drug.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • Chung Shan Medical University Hospital

    Taichung

  • Far Eastern Memorial Hospital

    Taipei

  • Taipei City Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis

This is a multi-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ENIA11 in patients with ankylosing spondylitis. The study period for each patient will be 27 weeks, during which the patient will undergo screening for up to 21 days, and followed by treatment of 24 weeks and follow up period of 2 weeks. Each patient will be required to make a total of 9 visits.

After re-confirming the eligibility of patients at Visit 2, eligible patients will be randomly assigned to either treatment group or control group in a 2:1 ratio. In addition, patients in the treatment group will receive ENIA11 25 mg twice weekly by subcutaneous injection while patients in the control group will receive placebo solution twice weekly by subcutaneous injection from Day 0 to week 12 and then switch to active drug from week 12 to week 24 and follow up period of 2 weeks.

The efficacy analysis, including ASAS response measures, ASAS5/6, ASDAS, BASDAS, BASFI, BASMI and individual measures of disease activity, such as numbers of swollen and tender joints, ESR and CRP, will be evaluated at each visit from Visit 2 (baseline) to Visit 9. Safety will be evaluated according to the frequency of adverse events, vital signs, physical examination, laboratory abnormalities, and ENIA11 antibody formation.

Being tested
ENIA11, Placebo
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • ENIA11Biological

  • PlaceboBiological

Study groups in NCT02685904
Study groupRoleWhat they receive
ENIA11Experimental25 mg of ENIA11 subcutaneously administered twice weekly
Receives: Biological: ENIA11
PlaceboPlacebo comparator25 mg of Placebo subcutaneously administered twice weekly
Receives: Biological: Placebo

What is being measured

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

  1. ASAS 20 responder at Week 12

    The proportion of patient achieving ASAS 20 will be calculated for the treatment group (RT) and the control group (RC)

    Measured: Week 12

Timeline

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

  1. First posted19 Feb 2016 (estimated)
  2. Study start6 Sep 2016
  3. Primary completion28 Jan 2018
  4. Study completion31 Dec 2018

Why it stopped: Sponsor's 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02685904
Sponsor's protocol ID
TSHEN1502
Status last verified
Mar 2019
First submitted
4 Feb 2016
Last updated
12 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ENIA11 in people with Ankylosing Spondylitis, run by Mycenax Biotech Inc. at 6 sites in Taiwan.

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 20 inclusion and 17 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.

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?

ASAS 20 responder at Week 12 (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 NCT02685904.

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 12 Mar 2019.

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