Beyond the gluten-free diet: Innovations in celiac disease therapeutics

Table 2 Phase 2 studies exploring gluten tolerance strategies in patients with celiac disease

NCT number (Acronym)	Study title	Study status (Completion date)	Drug	Mechanism	Primary outcome measures	Sponsor	Phases
NCT06001177 (SynCeD)	A study of efficacy, safety, and tolerability of KAN-101 in people with CD	Recruiting (June 2025)	KAN-101 vs placebo	KAN-101 acts by re-educating T cells, or tolerizing them, so they do not respond to gluten antigens	Changes from baseline in Vh:Cd as assessed by esophagogastroduodenoscopy with biopsy after 2-week gluten challenge	Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA	Phase 2
NCT05574010 (ACeD-it)	A study of safety, tolerability, pharmacodynamics, and pharmacokinetics of KAN-101 in CD	Recruiting (April 2, 2025)	Part A: Multiple ascending dose of KAN-101. Parts B and C: Participants will be randomized 1:1:1:1 to placebo and 3 treatment groups with KAN-101 doses based on information obtained from part A	KAN-101 acts by re-educating T cells, or tolerizing them, so they do not respond to gluten antigens	Severity of TEAEs assessed by common terminology criteria for adverse events (part A) at 28 days. Efficacy assessed by change in magnitude of IL-2 response pre- and post-germinal center (part B), baseline to day 15	Kanyos Bio, Inc., a wholly owned subsidiary of Anokion SA	Phase 1, Phase 2
NCT03738475	Study of the safety, pharmacodynamic, efficacy, and PK of TAK-101 in subjects with CD	Completed (July 22, 2019)	TAK-101 vs placebo	TAK-101, gliadin encapsulated in nanoparticles to induce gluten-specific tolerance	Change from baseline in interferon gamma spot-forming units based on results of a gliadin-specific enzyme-linked immunospot on day 20	Takeda	Phase 2
NCT04530123	Dose-ranging study of the efficacy and safety of TAK-101 for prevention of gluten-specific T-cell activation in participants with CD on a gluten-free diet	Active, not recruiting (May 29, 2024)	TAK-101 with or without gluten	TAK-101, gliadin encapsulated in nanoparticles to induce gluten-specific tolerance	Change from baseline in interferon gamma spot-forming units based on results of a gliadin-specific enzyme-linked immunospot on day 20	Takeda	Phase 2
NCT05660109	A study to assess the safety of TPM502 in adults with CD	Recruiting (May 30, 2024)	Drug: TPM502. Other: Placebo	TPM502 is a mixture of nanoparticles carrying gluten-specific antigenic peptides to the liver, to induce gluten tolerization	Incidence, severity, causality, and outcomes of TEAEs throughout the study, on average 43 days	Topas Therapeutics GmbH	Phase 2
NCT03644069	A study of the safety, efficacy and tolerability of Nexvax-2 in patients with CD	Unknown (September 2019)	Nexvax2 vs placebo	Nexvax2 is a therapeutic vaccine that desensitizes and induces gluten tolerance	Efficacy of Nexvax2 in reducing CD-associated GI symptoms, measured by the CD patient-reported outcome between baseline and the day of the first masked food challenge containing gluten	ImmusanT, Inc.	Phase 2

CD: Celiac disease; GI: Gastrointestinal; IL: Interleukin; TEAEs: Treatment-emergent adverse events; Vh:Cd: Villous height to crypt depth ratio.