Table 1.
Published clinical trials (up to August 2015).
| Trial ID | Subject of study | Patients | Gluten challenge | Dose range | Run in phase duration | Active phase duration |
|---|---|---|---|---|---|---|
| CLIN 1001-002 | The safety tolerance, pharmacokinetic and pharmacodynamic effects of single doses of AT-1001 in celiac disease subjects [Paterson et al. 2007] | 21 inpatients | YES 2.5 g (single dose) |
12 mg or placebo (single dose) | – | 3 days |
| CLIN 1001-004 | A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge [Leffler et al. 2012] | 86 outpatients | YES 0.8 g (3 times daily) |
0.25, 1, 4, 8 mg or placebo (3 times daily) |
– | 2 weeks |
| CLIN 1001-006 | Larazotide acetate in patients with coeliac disease undergoing a gluten challenge [Kelly et al. 2013] | 184 outpatients | YES 0.8 g (3 times daily) |
1, 4, 8 mg or placebo (3 times daily) |
7 days | 6 weeks |
| CLIN 1001-012 | Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet [Leffler et al. 2015] | 342 outpatients | NO | 0.5, 1, 2 mg or placebo (3 times daily) |
4 weeks | 12 weeks |