Ulcerative Colitis Chronic ModeratePhase 2NCT04504383
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
A Phase 2 study testing PN-943 in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by Protagonist Therapeutics, Inc. at 122 sites in 13 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
- What is being tested?
- PN-943
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 122 sitesin 13 countries
- Study dates
- 5 Aug 2020to 16 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
- Moderate to severe active UC.
- Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab).
Who cannot join
- Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
- History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
- 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.
- Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
- Positive stool test for C. difficile.
- Chronic recurrent or serious infection.
Show all 9Show fewer
- Known primary or secondary immunodeficiency.
- Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication.
- History of any major neurological disorders.
Trial locations and contacts
122 sites in 13 countries.
122 sites in 13 countries
United States31 sites
Protagonist Investigational Site
Austin, Texas, 78742
Protagonist Investigational Site
Charlotte, North Carolina, 28210
Protagonist Investigational Site
Chesterfield, Michigan, 48047
Protagonist Investigational Site
Colorado Springs, Colorado, 80907
Protagonist Investigational Site
Englewood, New Jersey, 07631
Protagonist Investigational Site
Garden Grove, California, 92845
Protagonist Investigational site
Garland, Texas, 75044
Protagonist Investigational Site
Glen Burnie, Maryland, 21061
Protagonist Investigational Site
Jackson, Mississippi, 39216
Protagonist Investigational Site
Kissimmee, Florida, 34741
Protagonist Investigational Site
Los Angeles, California, 90036
Protagonist Investigational site
Lynchburg, Virginia, 24502
Protagonist Investigational Site
Metairie, Louisiana, 70006
Protagonist Investigational Site
Miami, Florida, 33125
Protagonist Investigational Site
Miami, Florida, 33175
Protagonist Investigational Site
Miami, Florida, 33180
Protagonist Investigational Site
Murrieta, California, 92563
Protagonist Investigational Site
Nashville, Tennessee, 37212
Protagonist Investigational Site
Norman, Oklahoma, 73071
Protagonist Investigational Site
North Massapequa, New York, 11758
Protagonist Investigational Site
Oklahoma City, Oklahoma, 73103
Protagonist Investigational Site
Orangeburg, South Carolina, 29118
Protagonist Investigational site
Orlando, Florida, 32819
Protagonist Investigational Site
Pasadena, Texas, 77505
Protagonist Investigational Site
Saint Augustine, Florida, 32086
Protagonist Investigational Site
San Francisco, California, 94158
Protagonist Investigational Site
Spring, Texas, 77388
Protagonist Investigational Site
St Louis, Missouri, 63110
Protagonist Investigational Site
Troy, Michigan, 48098
Protagonist Investigational Site
Tucson, Arizona, 85712
Protagonist Investigational Site
Wesley Chapel, Florida, 33544
Poland28 sites
Protagonist Investigational Site
Bydgoszcz, 85-079
Protagonist Investigational Site
Bydgoszcz, 85794
Protagonist Investigational Site
Częstochowa, 42-200
Protagonist Investigational Site
Częstochowa, 42217
Protagonist Investigational Site
Katowice, 40-748
Protagonist Investigational Site
Krakow, 31-501
Protagonist Investigational Site
Ksawerów, 95-054
Protagonist Investigational Site
Lodz, 90-349
Protagonist Investigational Site
Lodz, 90-644
Protagonist Investigational Site
Lublin, 20-582
Protagonist Investigational Site
Nowy Targ, 34-400
Protagonist Investigational Site
Piotrkow Trybunalski, 97-300
Protagonist Investigational Site
Poznan, Greater Poland Voivodeship, 60-848
Protagonist Investigational Site
Poznan, 60-529
Protagonist Investigational Site
Poznan, 61-441
Protagonist Investigational Site
Rzeszów, 35-326
Protagonist Investigational Site
Sopot, 81-756
Protagonist Investigational Site
Swidnica, 58-100
Protagonist Investigational Site
Torun, 87-100
Protagonist Investigational Site
Tychy, 43-100
Protagonist Investigational Site
Warsaw, 00-332
Protagonist Investigational Site
Warsaw, 00-635
Protagonist Investigational Site
Warsaw, 00-728
Protagonist Investigational Site
Włocławek, 87-800
Protagonist Investigational Site
Wroclaw, 50449
Protagonist Investigational Site
Wroclaw, 51-162
Protagonist Investigational Site
Wroclaw, 51-685
Protagonist Investigational Site
Wroclaw, 52210
Russia15 sites
Protagonist Investigational Site
Chelyabinsk, 454076
Protagonist Investigational Site
Moscow, 105554
Protagonist Investigational Site
Novosibirsk, 630087
Protagonist Investigational Site
Novosibirsk
Protagonist Investigational Site
Perm, 614068
Protagonist Investigational Site
Pyatigorsk, 357500
Protagonist Investigational Site
Saint Petersburg, 196143
Protagonist Investigational Site
Saint Petersburg, 196257
Protagonist Investigational Site
Saint Petersburg, 197089
Protagonist Investigational Site
Saint Petersburg, 197110
Protagonist Investigational Site
Samara, 443029
Protagonist Investigational Site
Saratov, 410053
Protagonist Investigational Site
Stavropol, 355000
Protagonist Investigational Site
Tomsk, 634063
Protagonist Investigational Site
Tyumen, 625026
Ukraine9 sites
Protagonist Investigational Site
Ivano-Frankivsk, 76018
Protagonist Investigational Site
Kherson, 73000
Protagonist Investigational Site
Kyiv, 01030
Protagonist Investigational Site
Kyiv, 01103
Protagonist Investigational Site
Kyiv, 04073
Protagonist Investigational Site
Lviv, 79007
Protagonist Investigational Site
Vinnytsia, 21000
Protagonist Investigational Site
Vinnytsia, 21018
Protagonist Investigational Site
Zhytomyr, 10003
South Korea8 sites
Protagonist Investigational Site
Busan, 48079
Protagonist Investigational Site
Busan, 49201
Protagonist Investigational Site
Daegu, 42415
Protagonist Investigational Site
Daegu, 42601
Protagonist Investigational Site
Daejeon, 34943
Protagonist Investigational Site
Seoul, 06351
Protagonist Investigational Site
Seoul, 06591
Protagonist Investigational site
Seoul, 06973
Italy7 sites
Protagonist Investigational Site
Castellana Grotte, 70013
Protagonist Investigational Site
Modena, 41124
Protagonist Investigational Site
Negrar, 37024
Protagonist Investigational Site
Padova, 35128
Protagonist Investigational Site
Roma, 00152
Protagonist Investigational Site
Roma, 00168
Protagonist Investigational Site
San Giovanni Rotondo, 71013
Canada6 sites
Protagonist Investigational Site
Kelowna, British Columbia, V1Y 4N7
Protagonist Investigational Site
North Bay, Ontario, P1B 2H3
Protagonist Investigational Site
Toronto, Ontario, M5T 3A9
Protagonist Investigational Site
Vancouver, British Columbia, V6K 2K5
Protagonist Investigational Site
Vaughan, Ontario, L4L 4Y7
Protagonist Investigational Site
West Vancouver, British Columbia, V7T 1C5
Georgia5 sites
Protagonist Investigational Site
Tbilisi, 0141
Protagonist Investigational Site
Tbilisi, 0144
Protagonist Investigational Site
Tbilisi, 0159
Protagonist Investigational Site
Tbilisi, 0160
Protagonist Investigational Site
Tbilisi, 0186
Germany4 sites
Protagonist Investigational Site
Berlin, 14050
Protagonist Investigational Site
Berlin, 14163
Protagonist Investigational Site
Kiel, 24105
Protagonist Investigational Site
Tübingen, 72076
Austria3 sites
Protagonist Investigational Site
Innsbruck, 6020
Protagonist Investigational Site
Salzburg, 5020
Protagonist Investigational Site
Vienna, 1090
Hungary3 sites
Protagonist Investigational Site
Budapest, H-1033
Protagonist Investigational Site
Debrecen, 4025
Protagonist Investigational Site
Székesfehérvár, 8000
Bulgaria2 sites
Protagonist Investigational Site
Sofia, 1303
Protagonist Investigational Site
Sofia, 1407
About this study
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
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).
Read the 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.
- Being tested
- PN-943, Placebo
- Keywords
- Inflammatory Bowel Disease (IBD)
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN-943Drug
Administered by the oral route BID for the duration of the study.
PlaceboDrug
Administered by the oral route BID for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PN-943 450 mg BID | Experimental | Oral administration of PN-943 450 mg BID Receives: Drug: PN-943 |
| PN-943 150 mg BID | Experimental | Oral administration of PN-943 150 mg BID Receives: Drug: PN-943 |
| Placebo BID | Placebo comparator | Oral administration of matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
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)
Measured: Week 12
Secondary outcomes (1)
Comparison between PN-943 high-dose and low-dose individually to placebo.
- Proportion of subjects with endoscopic improvement.
- Proportion of subjects achieving endoscopic remission.
- Proportion of subjects with histological improvement.
- Proportion of subjects achieving histological remission.
- Proportion of subjects with mucosal healing.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start5 Aug 2020
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis Chronic ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protagonist Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504383
- Sponsor's protocol ID
- PN-943-03
- Status last verified
- Apr 2023
- First submitted
- 5 Aug 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04504383
- Acronym / sponsor ID
- PN-943-03
- Keywords
- Inflammatory Bowel Disease (IBD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Protagonist Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| PN-943 450 mg BID | Experimental | Drug: PN-943Oral administration of PN-943 450 mg BID |
| PN-943 150 mg BID | Experimental | Drug: PN-943Oral administration of PN-943 150 mg BID |
| Placebo BID | Placebo comparator | Drug: PlaceboOral administration of matching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC.
- Moderate to severe active UC.
- 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 (9 listed)
- Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis.
- History of colonic dysplasia other than completely removed low-grade dysplastic lesion.
- 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.
- Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study.
- Positive stool test for C. difficile.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PN-943Administered by the oral route BID for the duration of the study. | Drug | PN-943 150 mg BID, PN-943 450 mg BID |
| PlaceboAdministered by the oral route BID for 12 weeks. | Drug | Placebo BID |
Primary outcome
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)
1 secondary outcome
Comparison between PN-943 high-dose and low-dose individually to placebo.
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
122 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PN-943 in people with Ulcerative Colitis Chronic Moderate and Ulcerative Colitis Chronic Severe, run by Protagonist Therapeutics, Inc. at 122 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in United States, Poland, Russia, Ukraine, South Korea and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving clinical remission at Week 12 compared to placebo. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.