Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

Phase 2

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: PTG-100; Drug: Placebo

• Registration Number: NCT02895100
• Lead Sponsor: Protagonist Therapeutics, Inc.

Brief Summary

The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).

Detailed Description

This is a Phase II multi-centre, double blind, randomised, placebo-controlled, clinical study to evaluate the efficacy, safety, and tolerability of an oral peptide, PTG-100, administered as capsules for 12 weeks in subjects with moderate to severe UC.

Following screening procedures and confirmation of subject eligibility, subjects will be randomised 1:1:1:1 to one of three daily doses of PTG-100 (150, 300 or 900 mg) or placebo. Stratification will be based on subjects' prior treatment with anti-TNF agents, with a maximum of 50% of subjects with prior unsuccessful anti-TNF agent treatments. Subjects will be treated with study drug for 12 weeks. Sigmoidoscopies will be performed at the Screening Visit and on Week 12. A final Follow Up Visit will occur on Week 16, when subject has been off study treatment for 4 weeks. Clinical, safety, pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated on an ongoing basis during the 16 week study.

Study Timeline

• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Study Start: 2016-12
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Disposition First Submitted: 2019-02-28
• Disposition First Submitted QC: 2019-02-28
• Disposition First Posted: 2019-03-05
• Results First Submitted: 2021-02-22
• Results First Submitted QC: 2021-02-22
• Results First Posted: 2021-03-22
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTG-100 (300 mg QD)	PTG-100	Medium dose
PTG-100 (900 mg QD)	PTG-100	High dose
Placebo group	Placebo	Placebo control
PTG-100 (150 mg QD)	PTG-100	Low dose

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo	12 week treatment period	The primary efficacy endpoint for this study was the proportion of subjects receiving PTG-100 with clinical remission at Week 12. Clinical remission was defined using the Mayo subscores of stool frequency, rectal bleeding, and endoscopy.

Trial Locations

Locations (98)

Site Reference ID/Investigator # 547; 🇺🇦 Zaporizhzhya, Ukraine

Site Reference ID/Investigator # 509; 🇺🇦 Kharkov, Ukraine

Site Reference ID/Investigator # 101; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator # 102; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator # 120; 🇺🇸 Miami, Florida, United States

Site Reference ID/Investigator # 100; 🇺🇸 Atlanta, Georgia, United States

Site Reference ID/Investigator # 104; 🇺🇸 Marietta, Georgia, United States

Site Reference ID/Investigator # 109; 🇺🇸 Great Neck, New York, United States

Site Reference ID/Investigator # 563; 🇭🇺 Sopron, Hungary

Site Reference ID/Investigator # 521; 🇷🇸 Belgrade, Serbia

Site Reference ID/Investigator # 543; 🇷🇸 Niš, Serbia

Site Reference ID/Investigator # 507; 🇺🇦 Vinnytsya, Ukraine

Site Reference ID/Investigator # 125; 🇺🇸 Colorado Springs, Colorado, United States

Site Reference ID/Investigator # 106; 🇺🇸 Port Orange, Florida, United States

Site Reference ID/Investigator # 567; 🇭🇺 Eger, Hungary

Site Reference ID/Investigator # 546; 🇵🇱 Sopot, Poland

Site Reference ID/Investigator # 531; 🇵🇱 Wloclawek, Poland

Site Reference ID/Investigator # 902; 🇳🇿 Newton, New Zealand

Site Reference ID/Investigator # 906; 🇰🇷 Daegu, Korea, Republic of

Site Reference ID/Investigator # 557; 🇭🇺 Kistarcsa, Hungary

Site Reference ID/Investigator # 510; 🇺🇦 Chernivtsi, Ukraine

Site Reference ID/Investigator # 504; 🇺🇦 Uzhgorod, Ukraine

Site Reference ID/Investigator # 904; 🇰🇷 Seoul, Korea, Republic of

Site Reference ID/Investigator # 514; 🇷🇺 Saint Petersburg, Russian Federation

Site Reference ID/Investigator # 545; 🇱🇻 Riga, Latvia

Site Reference ID/Investigator # 512; 🇵🇱 Ksawerów, Poland

Site Reference ID/Investigator # 530; 🇵🇱 Lodz, Poland

Site Reference ID/Investigator # 518; 🇵🇱 Lodz, Poland

Site Reference ID/Investigator # 905; 🇰🇷 Seoul, Korea, Republic of

Site Reference ID/Investigator # 524; 🇷🇺 Moscow, Russian Federation

Site Reference ID/Investigator # 526; 🇷🇺 Rostov-na-Donu, Russian Federation

Site Reference ID/Investigator # 522; 🇷🇺 Saint Petersburg, Russian Federation

Site Reference ID/Investigator # 568; 🇳🇱 Amsterdam, Netherlands

Site Reference ID/Investigator # 903; 🇳🇿 Dunedin, New Zealand

Site Reference ID/Investigator # 536; 🇷🇺 Moskva, Russian Federation

Site Reference ID/Investigator # 553; 🇷🇺 Kazan', Russian Federation

Site Reference ID/Investigator # 501; 🇱🇻 Riga, Latvia

Site Reference ID/Investigator # 508; 🇺🇦 Kharkiv, Ukraine

Site Reference ID/Investigator # 565; 🇺🇦 Kyiv, Ukraine

Site Reference ID/Investigator # 534; 🇺🇦 L'viv, Ukraine

Site Reference ID/Investigator # 549; 🇺🇦 Kiev, Ukraine

Site Reference ID/Investigator # 901; 🇦🇺 Murdoch, Western Australia, Australia

Site Reference ID/Investigator # 571; 🇧🇦 Tuzla, Bosnia and Herzegovina

Site Reference ID/Investigator # 576; 🇵🇱 Kraków, Poland

Site Reference ID/Investigator # 544; 🇭🇺 Mosonmagyaróvár, Hungary

Site Reference ID/Investigator # 573; 🇧🇦 Mostar, Bosnia and Herzegovina

Site Reference ID/Investigator # 552; 🇭🇺 Debrecen, Hungary

Site Reference ID/Investigator # 529; 🇵🇱 Kielce, Poland

Site Reference ID/Investigator # 103; 🇨🇦 Vancouver, British Columbia, Canada

Site Reference ID/Investigator # 577; 🇵🇱 Poznań, Poland

Site Reference ID/Investigator # 540; 🇵🇱 Krakow, Poland

Site Reference ID/Investigator # 502; 🇷🇸 Zvezdara, Serbia

Site Reference ID/Investigator # 513; 🇵🇱 Warszawa, Poland

Site Reference ID/Investigator # 566; 🇷🇸 Belgrade, Serbia

Site Reference ID/Investigator # 500; 🇷🇸 Kragujevac, Serbia

Site Reference ID/Investigator # 515; 🇷🇺 Novosibirsk, Russian Federation

Site Reference ID/Investigator # 555; 🇷🇺 Saint Petersburg, Russian Federation

Site Reference ID/Investigator # 523; 🇷🇺 Samara, Russian Federation

Site Reference ID/Investigator # 551; 🇷🇺 Ufa, Russian Federation

Site Reference ID/Investigator # 525; 🇷🇺 Yaroslavl, Russian Federation

Site Reference ID/Investigator # 115; 🇺🇸 Saint Augustine, Florida, United States

Site Reference ID/Investigator # 112; 🇺🇸 Suwanee, Georgia, United States

Site Reference ID/Investigator # 116; 🇺🇸 Sweetwater, Florida, United States

Site Reference ID/Investigator # 505; 🇧🇪 Leuven, Belgium

Site Reference ID/Investigator # 126; 🇺🇸 Bastrop, Louisiana, United States

Site Reference ID/Investigator # 107; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator # 114; 🇺🇸 Shreveport, Louisiana, United States

Site Reference ID/Investigator # 110; 🇺🇸 Hermitage, Tennessee, United States

Site Reference ID/Investigator # 122; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator # 119; 🇺🇸 Cincinnati, Ohio, United States

Site Reference ID/Investigator # 117; 🇺🇸 Chevy Chase, Maryland, United States

Site Reference ID/Investigator # 128; 🇺🇸 Nashville, Tennessee, United States

Site Reference ID/Investigator # 118; 🇺🇸 DeSoto, Texas, United States

Site Reference ID/Investigator # 113; 🇺🇸 Richmond, Virginia, United States

Site Reference ID/Investigator # 908; 🇦🇺 Herston, Australia

Site Reference ID/Investigator # 900; 🇦🇺 South Brisbane, Australia

Site Reference ID/Investigator # 559; 🇧🇪 Gent, Belgium

Site Reference ID/Investigator # 907; 🇦🇺 Subiaco, Australia

Site Reference ID/Investigator # 550; 🇭🇷 Split, Croatia

Site Reference ID/Investigator # 105; 🇨🇦 London, Ontario, Canada

Site Reference ID/Investigator #556; 🇭🇷 Osijek, Croatia

Site Reference ID/Investigator # 562; 🇭🇷 Zagreb, Croatia

Site Reference ID/Investigator # 517; 🇨🇿 Nový Hradec Králové, Czechia

Site Reference ID/Investigator # 506; 🇩🇪 Leipzig, Germany

Site Reference ID/Investigator # 572; 🇩🇪 Mannheim, Germany

Site Reference ID/Investigator # 539; 🇨🇿 Zlín, Czechia

Site Reference ID/Investigator # 532; 🇩🇪 Kiel, Germany

Site Reference ID/Investigator # 574; 🇩🇪 Tuebingen, Germany

Site Reference ID/Investigator # 560; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator # 542; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator # 538; 🇩🇪 Münster, Germany

Site Reference ID/Investigator # 558; 🇭🇺 Budapest, Hungary

Site Reference ID/Investigator # 554; 🇭🇺 Budapest, Hungary

Site Reference ID/Investigator # 541; 🇩🇪 Ulm, Germany

Site Reference ID/Investigator # 575; 🇷🇸 Belgrade, Serbia

Site Reference ID/Investigator # 535; 🇺🇦 Ivano-Frankivs'k, Ukraine

Site Reference ID/Investigator # 520; 🇺🇦 Odessa, Ukraine

Site Reference ID/Investigator # 533; 🇧🇪 Kortrijk, Belgium