Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

NCT00620451 | Completed Phase 2 FDA Drug

• 1 other identifier: AT1001-011
• Study Type: interventional
• Target: 105
• Locations: 3 countries
• Sites: 33

Brief Summary

This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.

Conditions

Celiac Disease

Keywords

Treatment; Active; Celiac; Remission; Induction

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease

  Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.

  duodeno-jejunal biopsies were performed at Baseline and Day 56

Secondary Outcomes (4)

• Assess the safety and tolerability of larazotide acetate

  Up to 8 weeks

• To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole.

  Up to 8 weeks

• To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey.

  CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4.

• To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects

  Blood draws occurred at Visits 1, 2, 3, 4 and 5.

Study Arms (3)

Larazotide acetate 4 mg

EXPERIMENTAL

larazotide acetate capsules 4 mg TID

Drug: larazotide acetate

Larazotide acetate 8 mg

EXPERIMENTAL

Larazotide acetate capsules 8 mg TID

Drug: larazotide acetate

Placebo

PLACEBO COMPARATOR

Placebo capsules

Drug: placebo

Interventions

larazotide acetate DRUG

gelatin capsule

Also known as: AT-1001, INN-202

Larazotide acetate 4 mg; Larazotide acetate 8 mg

placebo DRUG

gelatin capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
• Marsh score ≥ II at screening
• Positive serum anti-tTG antibodies as determined by screening serology
• Willing to comply with a gluten-free diet for the duration of the study

You may not qualify if:

• Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
• Has chronic active GI disease other than Celiac Disease
• Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
• Has hemoglobin value below 8.5 g/dL

Sponsors & Collaborators

• 9 Meters Biopharma, Inc.: lead

Study Sites (33)

Study Site

Orange, California, 92868, United States

Location

Study Site

San Francisco, California, 94115, United States

Location

Study Site

Torrington, Connecticut, 06790, United States

Location

Study Site

Jacksonville, Florida, 32207, United States

Location

Study Site

Topeka, Kansas, 66606, United States

Location

Study Site

Lexington, Kentucky, 40536, United States

Location

Study Site

Hagerstown, Maryland, 21740, United States

Location

Study Site

Silver Spring, Maryland, 20901, United States

Location

Study Site

Chesterfield, Michigan, 48047, United States

Location

Study Site

Troy, Michigan, 48084, United States

Location

Study Site

Rochester, Minnesota, 55905, United States

Location

Study Site

Asheville, North Carolina, 28801, United States

Location

Study Site

Harrisburg, North Carolina, 28075, United States

Location

Study Site

Gallipolis, Ohio, 45631, United States

Location

Study Site

Paoli, Pennsylvania, 19301, United States

Location

Study Site

Philadelphia, Pennsylvania, 19014, United States

Location

Study Site

Pittsburgh, Pennsylvania, 15243, United States

Location

Study Site

Sioux Falls, South Dakota, 57105, United States

Location

Study Site

Franklin, Tennessee, 37067, United States

Location

Study Site

Houston, Texas, 77030, United States

Location

Study Site

Edmonton, Alberta, T6G2X8, Canada

Location

Study Site

Abbotsford, British Columbia, V5ZIH2, Canada

Location

Study Site

Kelowna, British Columbia, V1Y2H4, Canada

Location

Study Site

Richmond Hill, Ontario, L4B3PB, Canada

Location

Study Site

Palma, Mallorca, 07014, Spain

Location

Study Site

Barcelona, 08028, Spain

Location

Study Site

Huesca, 22004, Spain

Location

Study Site

León, 24005, Spain

Location

Study Site

Madrid, 28007, Spain

Location

Study Site

Madrid, 28034, Spain

Location

Study site

Madrid, 28040, Spain

Location

Study Site

Reus, 43201, Spain

Location

Study Site

Valladolid, 47005, Spain

Location

MeSH Terms

Conditions

Celiac Disease; Motor Activity

Interventions

larazotide acetate

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Francisco Leon, MD, Ph.D

  Alba Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, parallel- group, double-blind, multicenter

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

CA (4); ES (9); US (20)