Clinical trial NCT04504383: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis Chronic Moderate
Ulcerative Colitis Chronic Severe
Keywords: Inflammatory Bowel Disease (IBD)
Lead sponsor: Protagonist Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 12-week randomized, double-blind, placebo-controlled, parallel design study in patients with moderate to severe active UC. It will be followed by 40 weeks of Extended Active Treatment.
Primary purpose: TREATMENT

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 criteria: 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.

Primary outcomes:
measure: Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
timeFrame: Week 12
Secondary outcomes:
measure: Comparison between PN-943 high-dose and low-dose individually to placebo.
timeFrame: Week 12
Other outcomes:
measure: Proportion of subjects achieving clinical remission at Week 52.
timeFrame: Week 52
Locations:
city: Tucson
country: United States
facility: Protagonist Investigational Site
state: Arizona
city: Garden Grove
country: United States
facility: Protagonist Investigational Site
state: California
city: Los Angeles
country: United States
facility: Protagonist Investigational Site
state: California
city: Murrieta
country: United States
facility: Protagonist Investigational Site
state: California
city: San Francisco
country: United States
facility: Protagonist Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Protagonist Investigational Site
state: Colorado
city: Kissimmee
country: United States
facility: Protagonist Investigational Site
state: Florida
city: Miami
country: United States
facility: Protagonist Investigational Site
state: Florida
city: Miami
country: United States
facility: Protagonist Investigational Site
state: Florida
city: Miami
country: United States
facility: Protagonist Investigational Site
state: Florida
city: Orlando
country: United States
facility: Protagonist Investigational site
state: Florida
city: Saint Augustine
country: United States
facility: Protagonist Investigational Site
state: Florida
city: Wesley Chapel
country: United States
facility: Protagonist Investigational Site
state: Florida
city: Metairie
country: United States
facility: Protagonist Investigational Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Protagonist Investigational Site
state: Maryland
city: Chesterfield
country: United States
facility: Protagonist Investigational Site
state: Michigan
city: Troy
country: United States
facility: Protagonist Investigational Site
state: Michigan
city: Jackson
country: United States
facility: Protagonist Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Protagonist Investigational Site
state: Missouri
city: Englewood
country: United States
facility: Protagonist Investigational Site
state: New Jersey
city: North Massapequa
country: United States
facility: Protagonist Investigational Site
state: New York
city: Charlotte
country: United States
facility: Protagonist Investigational Site
state: North Carolina
city: Norman
country: United States
facility: Protagonist Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Protagonist Investigational Site
state: Oklahoma
city: Orangeburg
country: United States
facility: Protagonist Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Protagonist Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Protagonist Investigational Site
state: Texas
city: Garland
country: United States
facility: Protagonist Investigational site
state: Texas
city: Pasadena
country: United States
facility: Protagonist Investigational Site
state: Texas
city: Spring
country: United States
facility: Protagonist Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: Protagonist Investigational site
state: Virginia
city: Innsbruck
country: Austria
facility: Protagonist Investigational Site
city: Salzburg
country: Austria
facility: Protagonist Investigational Site
city: Vienna
country: Austria
facility: Protagonist Investigational Site
city: Sofia
country: Bulgaria
facility: Protagonist Investigational Site
city: Sofia
country: Bulgaria
facility: Protagonist Investigational Site
city: Kelowna
country: Canada
facility: Protagonist Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Protagonist Investigational Site
state: British Columbia
city: West Vancouver
country: Canada
facility: Protagonist Investigational Site
state: British Columbia
city: North Bay
country: Canada
facility: Protagonist Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Protagonist Investigational Site
state: Ontario
city: Vaughan
country: Canada
facility: Protagonist Investigational Site
state: Ontario
city: Tbilisi
country: Georgia
facility: Protagonist Investigational Site
city: Tbilisi
country: Georgia
facility: Protagonist Investigational Site
city: Tbilisi
country: Georgia
facility: Protagonist Investigational Site
city: Tbilisi
country: Georgia
facility: Protagonist Investigational Site
city: Tbilisi
country: Georgia
facility: Protagonist Investigational Site
city: Berlin
country: Germany
facility: Protagonist Investigational Site
city: Berlin
country: Germany
facility: Protagonist Investigational Site
city: Kiel
country: Germany
facility: Protagonist Investigational Site
city: Tuebingen
country: Germany
facility: Protagonist Investigational Site
city: Budapest
country: Hungary
facility: Protagonist Investigational Site
city: Debrecen
country: Hungary
facility: Protagonist Investigational Site
city: Székesfehérvár
country: Hungary
facility: Protagonist Investigational Site
city: Castellana Grotte
country: Italy
facility: Protagonist Investigational Site
city: Modena
country: Italy
facility: Protagonist Investigational Site
city: Negrar
country: Italy
facility: Protagonist Investigational Site
city: Padova
country: Italy
facility: Protagonist Investigational Site
city: Roma
country: Italy
facility: Protagonist Investigational Site
city: Roma
country: Italy
facility: Protagonist Investigational Site
city: San Giovanni Rotondo
country: Italy
facility: Protagonist Investigational Site
city: Busan
country: Korea, Republic of
facility: Protagonist Investigational Site
city: Busan
country: Korea, Republic of
facility: Protagonist Investigational Site
city: Daegu
country: Korea, Republic of
facility: Protagonist Investigational Site
city: Daegu
country: Korea, Republic of
facility: Protagonist Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Protagonist Investigational Site
city: Seoul
country: Korea, Republic of
facility: Protagonist Investigational Site
city: Seoul
country: Korea, Republic of
facility: Protagonist Investigational Site
city: Seoul
country: Korea, Republic of
facility: Protagonist Investigational site
city: Poznań
country: Poland
facility: Protagonist Investigational Site
state: Wielkopolskie
city: Bydgoszcz
country: Poland
facility: Protagonist Investigational Site
city: Bydgoszcz
country: Poland
facility: Protagonist Investigational Site
city: Czestochowa
country: Poland
facility: Protagonist Investigational Site
city: Czestochowa
country: Poland
facility: Protagonist Investigational Site
city: Katowice
country: Poland
facility: Protagonist Investigational Site
city: Kraków
country: Poland
facility: Protagonist Investigational Site
city: Ksawerów
country: Poland
facility: Protagonist Investigational Site
city: Lublin
country: Poland
facility: Protagonist Investigational Site
city: Nowy Targ
country: Poland
facility: Protagonist Investigational Site
city: Piotrków Trybunalski
country: Poland
facility: Protagonist Investigational Site
city: Poznań
country: Poland
facility: Protagonist Investigational Site
city: Poznań
country: Poland
facility: Protagonist Investigational Site
city: Rzeszów
country: Poland
facility: Protagonist Investigational Site
city: Sopot
country: Poland
facility: Protagonist Investigational Site
city: Swidnica
country: Poland
facility: Protagonist Investigational Site
city: Toruń
country: Poland
facility: Protagonist Investigational Site
city: Tychy
country: Poland
facility: Protagonist Investigational Site
city: Warsaw
country: Poland
facility: Protagonist Investigational Site
city: Warsaw
country: Poland
facility: Protagonist Investigational Site
city: Warszawa
country: Poland
facility: Protagonist Investigational Site
city: Wrocław
country: Poland
facility: Protagonist Investigational Site
city: Wrocław
country: Poland
facility: Protagonist Investigational Site
city: Wrocław
country: Poland
facility: Protagonist Investigational Site
city: Wrocław
country: Poland
facility: Protagonist Investigational Site
city: Włocławek
country: Poland
facility: Protagonist Investigational Site
city: Łódź
country: Poland
facility: Protagonist Investigational Site
city: Łódź
country: Poland
facility: Protagonist Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Protagonist Investigational Site
city: Moscow
country: Russian Federation
facility: Protagonist Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Protagonist Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Protagonist Investigational Site
city: Perm
country: Russian Federation
facility: Protagonist Investigational Site
city: Pyatigorsk
country: Russian Federation
facility: Protagonist Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Protagonist Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Protagonist Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Protagonist Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Protagonist Investigational Site
city: Samara
country: Russian Federation
facility: Protagonist Investigational Site
city: Saratow
country: Russian Federation
facility: Protagonist Investigational Site
city: Stavropol'
country: Russian Federation
facility: Protagonist Investigational Site
city: Tomsk
country: Russian Federation
facility: Protagonist Investigational Site
city: Tyumen
country: Russian Federation
facility: Protagonist Investigational Site
city: Zrenjanin
country: Serbia
facility: Protagonist Investigational Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Protagonist Investigational Site
city: Kherson
country: Ukraine
facility: Protagonist Investigational Site
city: Kyiv
country: Ukraine
facility: Protagonist Investigational Site
city: Kyiv
country: Ukraine
facility: Protagonist Investigational Site
city: Kyiv
country: Ukraine
facility: Protagonist Investigational Site
city: Lviv
country: Ukraine
facility: Protagonist Investigational Site
city: Vinnytsia
country: Ukraine
facility: Protagonist Investigational Site
city: Vinnytsia
country: Ukraine
facility: Protagonist Investigational Site
city: Zhytomyr
country: Ukraine
facility: Protagonist Investigational Site
Study officials:
References: