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Celiac DiseasePhase 2NCT01917630

Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

A Phase 2 study testing ALV003 in people with Celiac Disease, run by Alvine Pharmaceuticals Inc. at 88 sites in 6 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Celiac Disease
What is being tested?
ALV003
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
88 sitesin 6 countries
Study dates
Aug 2013to Jun 2015
Phase
Phase 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 18 to 80 years
  • Physician diagnosed celiac disease
  • Adherence to a gluten-free diet
  • Experiencing symptoms of celiac disease over a 1-month period
  • Willing to take study medication for 12 weeks
  • Willing to comply with all study procedures
  • Sign informed consent

Who cannot join

  • Active inflammatory bowel disease
  • Active dermatitis herpetiformis
  • Use of certain specific medications prior to entry
  • History of alcohol or illicit drug abuse in previous 6 months
  • Pregnant or lactating
  • Received any experimental drug within 30 days of enrollment
  • Uncontrolled chronic disease or condition

Trial locations and contacts

88 sites in 6 countries.

88 sites in 6 countries

United States79 sites

  • Study site

    Alexandria, Virginia, 22304

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Chattanooga, Tennessee, 37421

  • Study site

    Chesterfield, Michigan, 48047

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Dayton, Ohio, 45415

  • Study site

    Decatur, Alabama, 35601

  • Study site

    Des Moines, Iowa, 50266

  • Study site

    Evanston, Illinois, 60201

  • Study site

    Great Neck, New York, 11023

  • Study site

    Hermitage, Tennessee, 37076

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77094

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Huntsville, Alabama, 35802

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Irving, Texas, 75063

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Kansas City, Missouri, 64131

  • Study site

    Largo, Florida, 33777

  • Study site

    Los Angeles, California, 90025

  • Study site

    Los Angeles, California, 90027

  • Study site

    Madison, Wisconsin, 53705

  • Study site

    Malvern, Pennsylvania, 19355

  • Study site

    Marlton, New Jersey, 08053

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Mexico, Missouri, 65265

  • Study site

    Miami, Florida, 33137

  • Study site

    Miami, Florida, 33165

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Modesto, California, 95355

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Naples, Florida, 34102

  • Study site

    New York, New York, 10032

  • Study site

    Newport Beach, California, 92660

  • Study site

    Oak Lawn, Illinois, 60453

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32806

  • Study site

    Palo Alto, California, 94301

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Pittsburgh, Pennsylvania, 15243

  • Study site

    Portland, Oregon, 97225

  • Study site

    Poughkeepsie, New York, 12601

  • Study site

    Poway, California, 92064

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Rochester, New York, 14618

  • Study site

    Roseville, California, 95661

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    San Diego, California, 92114

  • Study site

    San Jose, California, 95117

  • Study site

    San Marcos, California, 92069

  • Study site

    Scottsdale, Arizona, 85259

  • Study site

    Scottsdale, Arizona, 85260

  • Study site

    Seattle, Washington, 98104

  • Study site

    Southlake, Texas, 76092

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Virginia Beach, Virginia, 23454

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyoming, Michigan, 49519

Other trials in United States

Canada5 sites

  • Study site

    Edmonton, Alberta, T6G 2X8

  • Study site

    Hamilton, Ontario, L8S 4K1

  • Study site

    Ottawa, Ontario, K2H 7B3

  • Study site

    Toronto, Ontario, M9C 4Z5

  • Study site

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Finland1 site

  • Study site

    Tampere

Other trials in Finland

Ireland1 site

  • Study site

    Galway

Other trials in Ireland

Norway1 site

  • Study site

    Oslo

Other trials in Norway

United Kingdom1 site

  • Study site

    Sheffield, S11 7FF

Other trials in United Kingdom

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet

To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

Conditions
Celiac Disease
Being tested
ALV003, placebo
Keywords
Celiac disease, Gluten-free diet, Coeliac disease, Celiac sprue
Medical subject headings
Celiac Disease

What participants receive

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

  • ALV003Drug

    ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)

  • placeboDrug

Study groups in NCT01917630
Study groupRoleWhat they receive
ALV003ExperimentalNot described
Receives: Drug: ALV003
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. Efficacy: Intestinal mucosal morphometry

    Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12

    Measured: 12 weeks

Secondary outcomes (2)

  1. Efficacy: Intestinal intraepithelial lymphocyte density

    Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)

    Measured: 12 weeks

  2. Safety: safety and tolerability of ALV003

    Incidence of adverse events between baseline and week 12

    Measured: 12 weeks

Timeline

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

  1. First posted7 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionApr 2015 (estimated)
  4. Study completionJun 2015 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917630
Sponsor's protocol ID
ALV003-1221
Status last verified
Dec 2014
First submitted
2 Aug 2013
Last updated
17 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Syage JA, Murray JA, Green PHR, Khosla C. Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. Dig Dis Sci. 2017 Sep;62(9):2428-2432. doi: 10.1007/s10620-017-4687-7. Epub 2017 Jul 28.

    PubMed 28755266

  • Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Maki M, Adelman DC; CeliAction Study Group of Investigators. No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. Gastroenterology. 2017 Mar;152(4):787-798.e2. doi: 10.1053/j.gastro.2016.11.004. Epub 2016 Nov 15.

    PubMed 27864127

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALV003 in people with Celiac Disease, run by Alvine Pharmaceuticals Inc. at 88 sites in 6 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 7 inclusion and 7 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 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Canada, Finland, Ireland, Norway and 1 more country. 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?

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?

Efficacy: Intestinal mucosal morphometry (time frame: 12 weeks). 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 NCT01917630, which also lists 2 linked publications.

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 17 Dec 2014.

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