Table 4.
Human clinical studies investigating the therapeutic applicability of larazotide acetate.
| Condition | Results | Study (Enrollment) |
Clinical Trials Identifier | Ref. |
|---|---|---|---|---|
| Healthy | good tolerability | Phase I (24) |
NCT00386490 | [196] |
| Celiac disease, gluten-free diet |
good tolerability | Phase Ib (21) |
NCT00386165 | [197] |
| Celiac disease, gluten challenge | improvement in GI symptoms, good tolerability |
Phase IIa (80) |
NCT00362856 | [198,199,200,201] |
| Celiac disease, gluten challenge | improvement in histological scores, good tolerability |
Phase IIb (105) |
NCT00620451 | [202,203] |
| Celiac disease, gluten challenge | improvement in GI symptoms, decreased level of anti-tTG IgA | Phase IIb (171) |
NCT00492960 | [204,205] |
| Celiac disease, persistent symptoms with gluten-free diet | improvement in GI and extra-GI symptoms, good tolerability |
Phase IIb (342) |
NCT01396213 | [206,207] |
| Celiac disease, gluten-free diet |
(terminated based on interim analysis) | Phase III (307) |
NCT03569007 | [208,209] |
| COVID19—MIS-C | improvement in clinical symptoms, decreased level of inflammatory markers and SARS-CoV-2 nucleocapsid (N) protein | case report (1) |
[178] | |
| COVID19—MIS-C | improvement in GI symptoms, decreased level of SARS-CoV-2 Spike (S) protein | case series (4) |
[210] | |
| COVID19—MIS-C | (not completed) | Phase IIa (20) |
NCT05022303 | [211] |
Abbreviations: Ref.: reference; GI: gastrointestinal; MIS-C: Multisystem Inflammatory Syndrome in Children.