Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01255696

Enrollment

Registered

2010-12-07

Start date

2010-11-30

Completion date

2011-06-30

Last updated

2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac Disease, Coeliac Disease, Celiac Sprue, Keliakia Disease

Brief summary

A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.

Interventions

BIOLOGICALALV003

BIOLOGICALALV003 placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* History of biopsy-proven celiac disease * Adherence to a gluten-free diet * TG2 antibody negative * Signed informed consent

Exclusion criteria

* Active dermatitis herpetiformis * History of IgE-mediated reactions to gluten * Use of specific medications 6 months prior to entry * History of alcohol abuse or illicit drug use * Current untreated or GI disease * Positive pregnancy test * Received any experimental drug within 14 days of randomization * Uncontrolled chronic disease or condition * Uncontrolled complications of celiac disease * Any medical condition which could adversely affect study participation

Design outcomes

Primary

Measure	Time frame	Description
Efficacy: Intestinal mucosal morphology	6 weeks	Intestinal mucosal morphology - change from baseline to week 6
Safety: Tolerability of ALV003	6 weeks	Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Secondary

Measure	Time frame	Description
Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype	6 weeks	Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6
Efficacy: Change in serological markers of celiac disease	6 weeks	Serological markers of celiac disease - change from baseline to week 6

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026