Celiac DiseasePhase 2NCT00959114
Safety and Efficacy of ALV003 for the Treatment of Celiac Disease
A Phase 2 study testing ALV003 in people with Celiac Disease, run by Alvine Pharmaceuticals Inc. at 1 site in Finland.
Trial summary
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 74 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2009to Oct 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of biopsy-proven celiac disease
- Adherence to a gluten-free diet
- TG2 antibody negative
- Signed informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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 participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With ALV003 In Patients With Well-Controlled Celiac Disease
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
Read the detailed description
Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.
- Conditions
- Celiac Disease
- Being tested
- ALV003, ALV003 placebo
- Keywords
- Celiac Disease, Coeliac Disease, Celiac Sprue, Keliakia
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALV003Biological
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
ALV003 placeboBiological
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase).
| Study group | Role | What they receive |
|---|---|---|
| ALV003 | Experimental | ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten. Receives: Biological: ALV003 |
| Placebo comparator | Placebo comparator | Excipients for ALV003 absent the experimental compounds Receives: Biological: ALV003 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Intestinal mucosal morphology
Measured: 6 weeks
Safety: Tolerability of ALV003
Measured: 6 weeks
Secondary outcomes (2)
Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
Measured: 6 weeks
Efficacy: Change in serological markers of celiac disease
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvine Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marja-Leena Lähdeaho, MD, PhD, Principal investigator, FINN-MEDI ResearchMarkku Mäki, Prof, MD, PhD, Study chair, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959114
- Sponsor's protocol ID
- ALV003-0921
- Status last verified
- Jul 2012
- First submitted
- 13 Aug 2009
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25.
PubMed 24583059
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With ALV003 In Patients With Well-Controlled Celiac Disease
- ClinicalTrials.gov ID
- NCT00959114
- Acronym / sponsor ID
- ALV003-0921
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Coeliac Disease, Celiac Sprue, Keliakia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Alvine Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
Detailed description
Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALV003 | Experimental | Biological: ALV003ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten. |
| Placebo comparator | Placebo comparator | Biological: ALV003 placeboExcipients for ALV003 absent the experimental compounds |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of biopsy-proven celiac disease
- Adherence to a gluten-free diet
- TG2 antibody negative
- Signed informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALV003ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase). | Biological | ALV003 |
| ALV003 placeboALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase). | Biological | Placebo comparator |
Primary outcome
Efficacy: Intestinal mucosal morphology
Time frame: 6 weeks
Safety: Tolerability of ALV003
Time frame: 6 weeks
2 secondary outcomes
Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
Time frame: 6 weeks
Efficacy: Change in serological markers of celiac disease
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Derived from this study: PubMed 24583059Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marja-Leena Lähdeaho, MD, PhD principal investigator
FINN-MEDI Research
Markku Mäki, Prof, MD, PhD study chair
Tampere University
1 site in 1 country: see every site and its status.
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 1 site in Finland.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 morphology (time frame: 6 weeks). The study lists 2 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 NCT00959114, which also lists 1 linked publication.
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 6 Aug 2012.