Ulcerative ColitisPhase 2NCT02895100
Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis
A Phase 2 study testing PTG-100 in people with Ulcerative Colitis, run by Protagonist Therapeutics, Inc. at 98 sites in 17 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- PTG-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 98 sitesin 17 countries
- Study dates
- Dec 2016to 26 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects age 18 to 80 years, inclusive
- Diagnosis of UC for at least 2 months prior to screening
- Moderate to severe active UC as defined by Mayo Score of 6 to 12 inclusive (range of 0-12) at baseline with endoscopy score of at least 2 (range 0-3)
- Subject must have had an inadequate response, loss of response to or intolerance to at least of of the following medications: immunomodulators, TNF-alpha antagonists or corticosteroids
- Subject is unlikely to conceive, as defined by one of the following: a) subject is male, b) subject is surgically sterilized female, c) subject is post-menopausal female >= 45 years of age with clinical documentation of menopause, or d) subject is woman of child bearing potential (WOCBP) and agrees to abstain from heterosexual activity, use adequate hormonal contraception or use double barrier contraception.
- For WOCBP, a negative pregnancy test at screening and within 24 hours of first dose of study medication
Who cannot join
- Subject has Crohn's Disease (CD), indeterminate colitis (IC) or presence or history of fistula with CD
- History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or is at imminent risk of colectomy
- History or current evidence of colonic dysplasia or adenomatous colonic polyps
- Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, infection with hepatitis B or C virus, infection with human immunodeficiency virus, infection requiring hospitalisation or intravenous antimicrobial therapy, or opportunistic infection within 6 months, any infection requiring antimicrobial therapy within 2 weeks, history of more than one episode of herpes zoster or any episode of disseminated zoster
- Live virus vaccination within one month prior to screening
- Subject has a concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results or poses additional risk to the subject
Show all 17Show fewer
- Known primary or secondary immunodeficiency
- History of myocardial infarction, unstable angina, transient ischaemic attack, decompensated heart failure requiring hospitalisation, congestive heart failure (NYHA Class 3 or 4), uncontrolled arrhythmias, cardiac revascularisation, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening
- Clinically meaningful laboratory abnormalities at screening
- Pregnant or lactating females
- Any surgical procedure requiring general anaesthesia within one month prior to screening, or planned elective surgery during the study
- History of malignant neoplasms or carcinoma in situ within 5 years prior to screening
- History of any major neurological disorders, as judged by the Investigator, or positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist
- Current or recent history of alcohol dependence or illicit drug use within 1 year prior to screening.
- Subject is mentally or legally incapacitated at the time of screening visit or has a history of clinically significant psychiatric disorders that would impact the subject's ability to participate in the trial according to the investigator
- Unable to attend study visits or comply with procedures
- Concurrent participation in any other interventional study.
Trial locations and contacts
98 sites in 17 countries.
98 sites in 17 countries
United States21 sites
Site Reference ID/Investigator # 100
Atlanta, Georgia, 30607
Site Reference ID/Investigator # 126
Bastrop, Louisiana, 71220
Site Reference ID/Investigator # 117
Chevy Chase, Maryland, 20815
Site Reference ID/Investigator # 107
Chicago, Illinois, 60611
Site Reference ID/Investigator # 119
Cincinnati, Ohio, 45219
Site Reference ID/Investigator # 125
Colorado Springs, Colorado, 80907
Site Reference ID/Investigator # 118
DeSoto, Texas, 75035
Site Reference ID/Investigator # 109
Great Neck, New York, 11021
Site Reference ID/Investigator # 110
Hermitage, Tennessee, 37076
Site Reference ID/Investigator # 101
Los Angeles, California, 90036
Site Reference ID/Investigator # 102
Los Angeles, California, 90036
Site Reference ID/Investigator # 104
Marietta, Georgia, 30060
Site Reference ID/Investigator # 120
Miami, Florida, 33126
Site Reference ID/Investigator # 128
Nashville, Tennessee, 37212
Site Reference ID/Investigator # 122
New York, New York, 10065
Site Reference ID/Investigator # 106
Port Orange, Florida, 32128
Site Reference ID/Investigator # 113
Richmond, Virginia, 23249
Site Reference ID/Investigator # 115
Saint Augustine, Florida, 32086
Site Reference ID/Investigator # 114
Shreveport, Louisiana, 71105
Site Reference ID/Investigator # 112
Suwanee, Georgia, 30024
Site Reference ID/Investigator # 116
Sweetwater, Florida, 33172
Russia11 sites
Site Reference ID/Investigator # 553
Kazan', 420029
Site Reference ID/Investigator # 524
Moscow, 125412
Site Reference ID/Investigator # 536
Moskva, 127015
Site Reference ID/Investigator # 515
Novosibirsk, 630117
Site Reference ID/Investigator # 526
Rostov-on-Don, 344022
Site Reference ID/Investigator # 514
Saint Petersburg, 191186
Site Reference ID/Investigator # 522
Saint Petersburg, 195067
Site Reference ID/Investigator # 555
Saint Petersburg, 195257
Site Reference ID/Investigator # 523
Samara, 443093
Site Reference ID/Investigator # 551
Ufa, 450071
Site Reference ID/Investigator # 525
Yaroslavl, 150000
Ukraine11 sites
Site Reference ID/Investigator # 510
Chernivtsi, 3110
Site Reference ID/Investigator # 535
Ivano-Frankivsk, 76018
Site Reference ID/Investigator # 509
Kharkiv, 6100
Site Reference ID/Investigator # 508
Kharkiv, 61039
Site Reference ID/Investigator # 549
Kiev
Site Reference ID/Investigator # 565
Kyiv, 2232
Site Reference ID/Investigator # 534
Lviv, 79059
Site Reference ID/Investigator # 520
Odesa, 65025
Site Reference ID/Investigator # 504
Uzhhorod, 88000
Site Reference ID/Investigator # 507
Vinnytsia, 21018
Site Reference ID/Investigator # 547
Zaporizhzhya, 609065
Poland10 sites
Site Reference ID/Investigator # 529
Kielce, 25-364
Site Reference ID/Investigator # 576
Krakow, 31-530
Site Reference ID/Investigator # 540
Krakow, 31-531
Site Reference ID/Investigator # 512
Ksawerów, 95-054
Site Reference ID/Investigator # 530
Lodz, 90-153
Site Reference ID/Investigator # 518
Lodz, 90-302
Site Reference ID/Investigator # 577
Poznan, 61-845
Site Reference ID/Investigator # 546
Sopot, 81-756
Site Reference ID/Investigator # 513
Warsaw, 00-632
Site Reference ID/Investigator # 531
Włocławek, 87-806
Germany8 sites
Site Reference ID/Investigator # 560
Berlin, 13353
Site Reference ID/Investigator # 542
Berlin, 14050
Site Reference ID/Investigator # 532
Kiel, 24105
Site Reference ID/Investigator # 506
Leipzig, 4103
Site Reference ID/Investigator # 572
Mannheim, 68167
Site Reference ID/Investigator # 538
Münster, 48149
Site Reference ID/Investigator # 574
Tübingen, 72076
Site Reference ID/Investigator # 541
Ulm, 89073
Hungary7 sites
Site Reference ID/Investigator # 554
Budapest, 1036
Site Reference ID/Investigator # 558
Budapest, 1125
Site Reference ID/Investigator # 552
Debrecen, 4032
Site Reference ID/Investigator # 567
Eger, 3300
Site Reference ID/Investigator # 557
Kistarcsa, 2143
Site Reference ID/Investigator # 544
Mosonmagyaróvár, 9200
Site Reference ID/Investigator # 563
Sopron, 9400
Serbia6 sites
Site Reference ID/Investigator # 521
Belgrade, 0 11080
Site Reference ID/Investigator # 575
Belgrade, 11000
Site Reference ID/Investigator # 566
Belgrade, 11080
Site Reference ID/Investigator # 500
Kragujevac, 12 34111
Site Reference ID/Investigator # 543
Niš, 18105
Site Reference ID/Investigator # 502
Zvezdara, 0 11050
Australia4 sites
Site Reference ID/Investigator # 908
Herston, 4006
Site Reference ID/Investigator # 901
Murdoch, Western Australia, 6150
Site Reference ID/Investigator # 900
South Brisbane, 4101
Site Reference ID/Investigator # 907
Subiaco, 6008
Belgium3 sites
Site Reference ID/Investigator # 559
Ghent, 9000
Site Reference ID/Investigator # 533
Kortrijk, 8500
Site Reference ID/Investigator # 505
Leuven, 3000
Croatia3 sites
Site Reference ID/Investigator #556
Osijek, 31000
Site Reference ID/Investigator # 550
Split, 17 21000
Site Reference ID/Investigator # 562
Zagreb, 21 10000
South Korea3 sites
Site Reference ID/Investigator # 906
Daegu, 42415
Site Reference ID/Investigator # 905
Seoul, 06591
Site Reference ID/Investigator # 904
Seoul, 3722
Bosnia and Herzegovina2 sites
Site Reference ID/Investigator # 573
Mostar, 88000
Site Reference ID/Investigator # 571
Tuzla, 3 75000
Canada2 sites
Site Reference ID/Investigator # 105
London, Ontario, N6A 5A5
Site Reference ID/Investigator # 103
Vancouver, British Columbia, V6Z 2K5
Czechia2 sites
Site Reference ID/Investigator # 517
Nový Hradec Králové, 500 12
Site Reference ID/Investigator # 539
Zlín, 76275
Latvia2 sites
Site Reference ID/Investigator # 501
Riga, 1002
Site Reference ID/Investigator # 545
Riga, LV-1002
New Zealand2 sites
Site Reference ID/Investigator # 903
Dunedin, 9016
Site Reference ID/Investigator # 902
Newton, 6021
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- PTG-100, Placebo
- Keywords
- ulcerative colitis, inflammatory bowel disease, PROPEL, Propel Study
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTG-100Drug
Daily dosing of PTG-100 by subject for a 12 week treatment period.
PlaceboDrug
Daily dosing of Placebo capsules by subject for a 12 week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| PTG-100 (150 mg QD) | Experimental | Low dose Receives: Drug: PTG-100 |
| PTG-100 (300 mg QD) | Experimental | Medium dose Receives: Drug: PTG-100 |
| PTG-100 (900 mg QD) | Experimental | High dose Receives: Drug: PTG-100 |
| Placebo group | Placebo comparator | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo
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.
Measured: 12 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion26 Mar 2018
- Study completion26 Mar 2018
Why it stopped: Data Monitoring Committee discontinued the trial due to futility-based outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protagonist Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director Clinical Development, Study director, Protagonist Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895100
- Sponsor's protocol ID
- PTG-100-02
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2016
- Last updated
- 21 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Sandborn WJ, Mattheakis LC, Modi NB, Pugatch D, Bressler B, Lee S, Bhandari R, Kanwar B, Shames R, D'Haens G, Schreiber S, Danese S, Feagan B, Pai RK, Liu DY, Gupta S. PTG-100, an Oral alpha4beta7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis. Gastroenterology. 2021 Dec;161(6):1853-1864.e10. doi: 10.1053/j.gastro.2021.08.045. Epub 2021 Aug 30.
PubMed 34474038
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02895100
- Acronym / sponsor ID
- PTG-100-02
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, inflammatory bowel disease, PROPEL, Propel Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data Monitoring Committee discontinued the trial due to futility-based outcome
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Protagonist Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Posted 22 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PTG-100 (150 mg QD) | Experimental | Drug: PTG-100Low dose |
| PTG-100 (300 mg QD) | Experimental | Drug: PTG-100Medium dose |
| PTG-100 (900 mg QD) | Experimental | Drug: PTG-100High dose |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects age 18 to 80 years, inclusive
- Diagnosis of UC for at least 2 months prior to screening
- Moderate to severe active UC as defined by Mayo Score of 6 to 12 inclusive (range of 0-12) at baseline with endoscopy score of at least 2 (range 0-3)
- Subject must have had an inadequate response, loss of response to or intolerance to at least of of the following medications: immunomodulators, TNF-alpha antagonists or corticosteroids
- Subject is unlikely to conceive, as defined by one of the following: a) subject is male, b) subject is surgically sterilized female, c) subject is post-menopausal female >= 45 years of age with clinical documentation of menopause, or d) subject is woman of child bearing potential (WOCBP) and agrees to abstain from heterosexual activity, use adequate hormonal contraception or use double barrier contraception.
Key exclusion criteria (17 listed)
- Subject has Crohn's Disease (CD), indeterminate colitis (IC) or presence or history of fistula with CD
- History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or is at imminent risk of colectomy
- History or current evidence of colonic dysplasia or adenomatous colonic polyps
- Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, infection with hepatitis B or C virus, infection with human immunodeficiency virus, infection requiring hospitalisation or intravenous antimicrobial therapy, or opportunistic infection within 6 months, any infection requiring antimicrobial therapy within 2 weeks, history of more than one episode of herpes zoster or any episode of disseminated zoster
- Live virus vaccination within one month prior to screening
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 |
|---|---|---|
| PTG-100Daily dosing of PTG-100 by subject for a 12 week treatment period. | Drug | PTG-100 (150 mg QD), PTG-100 (300 mg QD), PTG-100 (900 mg QD) |
| PlaceboDaily dosing of Placebo capsules by subject for a 12 week treatment period. | Drug | Placebo group |
Primary outcome
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34474038Sandborn WJ, Mattheakis LC, Modi NB, Pugatch D, Bressler B, Lee S, Bhandari R, Kanwar B, Shames R, D'Haens G, Schreiber S, Danese S, Feagan B, Pai RK, Liu DY, Gupta S. PTG-100, an Oral alpha4beta7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis. Gastroenterology. 2021 Dec;161(6):1853-1864.e10. doi: 10.1053/j.gastro.2021.08.045. Epub 2021 Aug 30.
- Individual participant dataSharing planned: Undecided
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Director Clinical Development study director
Protagonist Therapeutics, Inc.
98 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTG-100 in people with Ulcerative Colitis, run by Protagonist Therapeutics, Inc. at 98 sites in 17 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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Russia, Ukraine, Poland, Germany and 12 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?
Yes. Results are posted in the registry (first posted 22 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo (time frame: 12 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895100, which also lists 1 linked publication.
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 21 Aug 2025.