The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten.
This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.

开始日期2021-02-26

申办/合作机构

Protagonist Therapeutics, Inc.

NL-OMON45322 / Completed临床2期

A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS - PTG-100-02

开始日期2017-11-09

申办/合作机构

Protagonist Therapeutics, Inc.

EUCTR2016-003452-75-HR / Not yet recruiting临床2期

开始日期2017-05-11

申办/合作机构

Protagonist Therapeutics, Inc.

100 项与 PTG-100 相关的临床结果

登录后查看更多信息

100 项与 PTG-100 相关的转化医学

登录后查看更多信息

100 项与 PTG-100 相关的专利（医药）

登录后查看更多信息

项与 PTG-100 相关的文献（医药）

2021-12-01·Gastroenterology1区 · 医学

PTG-100, an Oral α4β7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis

1区 · 医学

Article

作者: Danese, Silvio ; Shames, Richard ; Gupta, Suneel ; D'Haens, Geert ; Schreiber, Stefan ; Sandborn, William J ; Modi, Nishit B ; Pugatch, David ; Feagan, Brian ; Lee, Scott ; Kanwar, Bittoo ; Mattheakis, Larry C ; Pai, Rish K ; Bhandari, Raj ; Liu, David Y ; Bressler, Brian

BACKGROUND & AIMS:

Oral therapies targeting the integrin α4β7 may offer unique advantages for the treatment of inflammatory bowel disease. We characterized the oral α4β7 antagonist peptide PTG-100 in preclinical models and established safety, pharmacokinetic/pharmacodynamic relationships, and efficacy in a phase 2a trial in patients with ulcerative colitis (UC).

METHODS:

In vitro studies measured binding properties of PTG-100. Mouse studies measured biomarkers and drug concentrations in blood and tissues. The phase 1 study involved healthy volunteers. In phase 2a, patients with moderate to severe active UC were randomized to receive PTG-100 (150, 300, or 900 mg) or placebo once daily for 12-weeks.

RESULTS:

PTG-100 potently and selectively blocks α4β7. Oral dosing of PTG-100 in mice showed high levels of target engagement and exposure in gut-associated lymphoid tissues. In healthy volunteers, PTG-100 showed dose-dependent increases in plasma exposure and blood target engagement. Although this phase 2a study initially did not meet the primary endpoint, a blinded reread of the endoscopy videos by a third party indicated clinical efficacy in conjunction with histologic remission at doses correlating with less than 100% receptor occupancy in peripheral blood.

CONCLUSIONS:

PTG-100 showed local gastrointestinal tissue target engagement and inhibition of memory T-cell trafficking in mice. It was safe and well tolerated in phase 1 and 2 studies. Phase 2a data are consistent with biological and clinical response and showed a dose response reflecting similar activities in preclinical models and healthy individuals. These data suggest that local gut activity of an oral α4β7 integrin antagonist, distinct from full target engagement in blood, are important for efficacy and the treatment of UC. (ClinicalTrials.gov, Number NCT02895100; EudraCT, Number 2016-003452-75).

2021-10-03·Expert opinion on investigational drugs2区 · 医学

Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents

2区 · 医学

Review

作者: Ragaini, Elisa ; Parigi, Tommaso Lorenzo ; Danese, Silvio ; Solitano, Virginia

INTRODUCTION:

Despite huge and increasing developments in the treatment of inflammatory bowel disease (IBD), a significant percentage of patients with Crohn's disease (CD) and ulcerative colitis (UC) is still in need of an effective and safe therapeutic option. Tackling the trafficking of leukocytes specifically within or directed to the inflamed gut appears to be a particularly promising strategy, and several new anti-integrin agents are currently under investigation in clinical trials.

AREAS COVERED:

This review summarizes efficacy and safety data from phase 1, 2 and 3 clinical trials on investigational drugs, including monoclonal antibodies (etrolizumab, abrilumab, ontamalimab) and oral small molecules (AJM300, PTG-100). It also discusses the future perspectives for the treatment of IBD patients with this class of agents.

EXPERT OPINION:

The pipeline of anti-integrin agents is well assorted, and it is reasonable to expect that some will be introduced in the market soon. Among the most exciting features of this class are the gut selectivity, the convenient subcutaneous and oral administrations and the reassuring safety profiles. Most of the new anti-integrins seem to improve outcomes in UC but not in CD, however these data are far from definitive and several pivotal trials are still under way.

100 项与 PTG-100 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
溃疡性结肠炎	临床2期	美国	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	澳大利亚	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	比利时	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	波斯尼亚和黑塞哥维那	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	加拿大	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	克罗地亚	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	捷克	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	德国	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	匈牙利	Protagonist Therapeutics, Inc.	2016-12-01
溃疡性结肠炎	临床2期	拉脱维亚	Protagonist Therapeutics, Inc.	2016-12-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02895100 (CTgov)	临床2期	溃疡性结肠炎	98	PTG-100 (PTG-100 (150 mg QD))	築廠衊製繭鏇鬱鹹憲蓋(糧廠鹹壓構顧觸窪築繭) = 艱衊繭鏇選築憲夢淵構製鏇觸構繭齋壓衊遞網 (鹽憲製鑰餘艱襯繭鹹繭, 網獵遞鹹觸願願獵鏇製 ~ 衊壓淵餘範遞築獵壓廠) 更多	-	2021-03-22
				PTG-100 (PTG-100 (300 mg QD))	築廠衊製繭鏇鬱鹹憲蓋(糧廠鹹壓構顧觸窪築繭) = 壓艱襯鏇鑰鹹廠遞獵餘製鏇觸構繭齋壓衊遞網 (鹽憲製鑰餘艱襯繭鹹繭, 齋遞艱簾淵壓齋鑰築齋 ~ 糧簾鏇積窪顧膚糧糧鹹) 更多