--- title: PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC) nct_id: NCT04504383 overall_status: COMPLETED phase: PHASE2 sponsor: Protagonist Therapeutics, Inc. study_type: INTERVENTIONAL primary_condition: Ulcerative Colitis Chronic Moderate countries: United States, Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Poland, Russia, Serbia, South Korea, Ukraine canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04504383.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04504383" ct_last_update_post_date: 2023-04-25 last_seen_at: "2026-05-12T06:20:16.114Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC) **Official Title:** A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis **NCT ID:** [NCT04504383](https://clinicaltrials.gov/study/NCT04504383) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 169 - **Lead Sponsor:** Protagonist Therapeutics, Inc. - **Conditions:** Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe - **Start Date:** 2020-08-05 - **Completion Date:** 2023-02-16 - **CT.gov Last Update:** 2023-04-25 ## Brief Summary The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily \[BID\] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC). ## Detailed Description The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID. Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Key Inclusion Criteria: 1. Male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years. 2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. 3. Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC. 4. Moderate to severe active UC. 5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab). Key Exclusion Criteria: 1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis. 2. History of colonic dysplasia other than completely removed low-grade dysplastic lesion. 3. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening. 4. Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study. 5. Positive stool test for C. difficile. 6. Chronic recurrent or serious infection. 7. Known primary or secondary immunodeficiency. 8. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication. 9. History of any major neurological disorders. ``` ## Arms - **PN-943 450 mg BID** (EXPERIMENTAL) — Oral administration of PN-943 450 mg BID - **PN-943 150 mg BID** (EXPERIMENTAL) — Oral administration of PN-943 150 mg BID - **Placebo BID** (PLACEBO_COMPARATOR) — Oral administration of matching placebo ## Interventions - **PN-943** (DRUG) — Administered by the oral route BID for the duration of the study. - **Placebo** (DRUG) — Administered by the oral route BID for 12 weeks. ## Primary Outcomes - **Proportion of subjects achieving clinical remission at Week 12 compared to placebo.** _(time frame: Week 12)_ — Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): * Stool frequency subscore (SFS) * Rectal bleeding subscore (RBS) * Endoscopic subscore (ESS) ## Secondary Outcomes - **Comparison between PN-943 high-dose and low-dose individually to placebo.** _(time frame: Week 12)_ ## Locations (122) - Protagonist Investigational Site, Tucson, Arizona, United States - Protagonist Investigational Site, Garden Grove, California, United States - Protagonist Investigational Site, Los Angeles, California, United States - Protagonist Investigational Site, Murrieta, California, United States - Protagonist Investigational Site, San Francisco, California, United States - Protagonist Investigational Site, Colorado Springs, Colorado, United States - Protagonist Investigational Site, Kissimmee, Florida, United States - Protagonist Investigational Site, Miami, Florida, United States - Protagonist Investigational Site, Miami, Florida, United States - Protagonist Investigational Site, Miami, Florida, United States - Protagonist Investigational site, Orlando, Florida, United States - Protagonist Investigational Site, Saint Augustine, Florida, United States - Protagonist Investigational Site, Wesley Chapel, Florida, United States - Protagonist Investigational Site, Metairie, Louisiana, United States - Protagonist Investigational Site, Glen Burnie, Maryland, United States - Protagonist Investigational Site, Chesterfield, Michigan, United States - Protagonist Investigational Site, Troy, Michigan, United States - Protagonist Investigational Site, Jackson, Mississippi, United States - Protagonist Investigational Site, St Louis, Missouri, United States - Protagonist Investigational Site, Englewood, New Jersey, United States - Protagonist Investigational Site, North Massapequa, New York, United States - Protagonist Investigational Site, Charlotte, North Carolina, United States - Protagonist Investigational Site, Norman, Oklahoma, United States - Protagonist Investigational Site, Oklahoma City, Oklahoma, United States - Protagonist Investigational Site, Orangeburg, South Carolina, United States - Protagonist Investigational Site, Nashville, Tennessee, United States - Protagonist Investigational Site, Austin, Texas, United States - Protagonist Investigational site, Garland, Texas, United States - Protagonist Investigational Site, Pasadena, Texas, United States - Protagonist Investigational Site, Spring, Texas, United States - Protagonist Investigational site, Lynchburg, Virginia, United States - Protagonist Investigational Site, Innsbruck, Austria - Protagonist Investigational Site, Salzburg, Austria - Protagonist Investigational Site, Vienna, Austria - Protagonist Investigational Site, Sofia, Bulgaria - Protagonist Investigational Site, Sofia, Bulgaria - Protagonist Investigational Site, Kelowna, British Columbia, Canada - Protagonist Investigational Site, Vancouver, British Columbia, Canada - Protagonist Investigational Site, West Vancouver, British Columbia, Canada - Protagonist Investigational Site, North Bay, Ontario, Canada - Protagonist Investigational Site, Toronto, Ontario, Canada - Protagonist Investigational Site, Vaughan, Ontario, Canada - Protagonist Investigational Site, Tbilisi, Georgia - Protagonist Investigational Site, Tbilisi, Georgia - Protagonist Investigational Site, Tbilisi, Georgia - Protagonist Investigational Site, Tbilisi, Georgia - Protagonist Investigational Site, Tbilisi, Georgia - Protagonist Investigational Site, Berlin, Germany - Protagonist Investigational Site, Berlin, Germany - Protagonist Investigational Site, Kiel, Germany - Protagonist Investigational Site, Tübingen, Germany - Protagonist Investigational Site, Budapest, Hungary - Protagonist Investigational Site, Debrecen, Hungary - Protagonist Investigational Site, Székesfehérvár, Hungary - Protagonist Investigational Site, Castellana Grotte, Italy - Protagonist Investigational Site, Modena, Italy - Protagonist Investigational Site, Negrar, Italy - Protagonist Investigational Site, Padova, Italy - Protagonist Investigational Site, Roma, Italy - Protagonist Investigational Site, Roma, Italy - Protagonist Investigational Site, San Giovanni Rotondo, Italy - Protagonist Investigational Site, Poznan, Greater Poland Voivodeship, Poland - Protagonist Investigational Site, Bydgoszcz, Poland - Protagonist Investigational Site, Bydgoszcz, Poland - Protagonist Investigational Site, Częstochowa, Poland - Protagonist Investigational Site, Częstochowa, Poland - Protagonist Investigational Site, Katowice, Poland - Protagonist Investigational Site, Krakow, Poland - Protagonist Investigational Site, Ksawerów, Poland - Protagonist Investigational Site, Lodz, Poland - Protagonist Investigational Site, Lodz, Poland - Protagonist Investigational Site, Lublin, Poland - Protagonist Investigational Site, Nowy Targ, Poland - Protagonist Investigational Site, Piotrkow Trybunalski, Poland - Protagonist Investigational Site, Poznan, Poland - Protagonist Investigational Site, Poznan, Poland - Protagonist Investigational Site, Rzeszów, Poland - Protagonist Investigational Site, Sopot, Poland - Protagonist Investigational Site, Swidnica, Poland - Protagonist Investigational Site, Torun, Poland - Protagonist Investigational Site, Tychy, Poland - Protagonist Investigational Site, Warsaw, Poland - Protagonist Investigational Site, Warsaw, Poland - Protagonist Investigational Site, Warsaw, Poland - Protagonist Investigational Site, Wroclaw, Poland - Protagonist Investigational Site, Wroclaw, Poland - Protagonist Investigational Site, Wroclaw, Poland - Protagonist Investigational Site, Wroclaw, Poland - Protagonist Investigational Site, Włocławek, Poland - Protagonist Investigational Site, Chelyabinsk, Russia - Protagonist Investigational Site, Moscow, Russia - Protagonist Investigational Site, Novosibirsk, Russia - Protagonist Investigational Site, Novosibirsk, Russia - Protagonist Investigational Site, Perm, Russia - Protagonist Investigational Site, Pyatigorsk, Russia - Protagonist Investigational Site, Saint Petersburg, Russia - Protagonist Investigational Site, Saint Petersburg, Russia - Protagonist Investigational Site, Saint Petersburg, Russia - Protagonist Investigational Site, Saint Petersburg, Russia - Protagonist Investigational Site, Samara, Russia - Protagonist Investigational Site, Saratov, Russia - Protagonist Investigational Site, Stavropol, Russia - Protagonist Investigational Site, Tomsk, Russia - Protagonist Investigational Site, Tyumen, Russia - Protagonist Investigational Site, Zrenjanin, Serbia - Protagonist Investigational Site, Busan, South Korea - Protagonist Investigational Site, Busan, South Korea - Protagonist Investigational Site, Daegu, South Korea - Protagonist Investigational Site, Daegu, South Korea - Protagonist Investigational Site, Daejeon, South Korea - Protagonist Investigational Site, Seoul, South Korea - Protagonist Investigational Site, Seoul, South Korea - Protagonist Investigational site, Seoul, South Korea - Protagonist Investigational Site, Ivano-Frankivsk, Ukraine - Protagonist Investigational Site, Kherson, Ukraine - Protagonist Investigational Site, Kyiv, Ukraine - Protagonist Investigational Site, Kyiv, Ukraine - Protagonist Investigational Site, Kyiv, Ukraine - Protagonist Investigational Site, Lviv, Ukraine - Protagonist Investigational Site, Vinnytsia, Ukraine - Protagonist Investigational Site, Vinnytsia, Ukraine - Protagonist Investigational Site, Zhytomyr, Ukraine ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.protagonist investigational site|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|garden grove|california|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|los angeles|california|united states` — added _(2026-05-12)_ - 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`locations.protagonist investigational site|chesterfield|michigan|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|troy|michigan|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|jackson|mississippi|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|englewood|new jersey|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|north massapequa|new york|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|charlotte|north carolina|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|norman|oklahoma|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|orangeburg|south carolina|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|austin|texas|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|garland|texas|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|pasadena|texas|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|spring|texas|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|lynchburg|virginia|united states` — added _(2026-05-12)_ - `locations.protagonist investigational site|innsbruck||austria` — added _(2026-05-12)_ - `locations.protagonist investigational site|salzburg||austria` — added _(2026-05-12)_ - `locations.protagonist investigational site|vienna||austria` — added _(2026-05-12)_ - `locations.protagonist investigational site|sofia||bulgaria` — added _(2026-05-12)_ - `locations.protagonist investigational site|kelowna|british columbia|canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04504383.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04504383* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*