Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
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ClinicalTrials.gov Identifier: NCT01917630 |
Recruitment Status : Unknown
Verified December 2014 by Alvine Pharmaceuticals Inc..
Recruitment status was: Active, not recruiting
First Posted : August 7, 2013
Last Update Posted : December 17, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Celiac Disease | Drug: ALV003 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | August 2013 |
Estimated Primary Completion Date : | April 2015 |
Estimated Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: ALV003 |
Drug: ALV003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) |
Placebo Comparator: Placebo |
Drug: placebo |
- Efficacy: Intestinal mucosal morphometry [ Time Frame: 12 weeks ]Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
- Efficacy: Intestinal intraepithelial lymphocyte density [ Time Frame: 12 weeks ]Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
- Safety: safety and tolerability of ALV003 [ Time Frame: 12 weeks ]Incidence of adverse events between baseline and week 12
- Celiac disease-specific serology [ Time Frame: 12 weeks ]
- Quality of life [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917630

Study Director: | Daniel Adelman, MD | Alvine Pharmaceuticals Inc. |
Responsible Party: | Alvine Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT01917630 |
Other Study ID Numbers: |
ALV003-1221 |
First Posted: | August 7, 2013 Key Record Dates |
Last Update Posted: | December 17, 2014 |
Last Verified: | December 2014 |
Celiac disease Gluten-free diet Coeliac disease Celiac sprue |
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |