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PL8177

Phase 2

Ulcerative Colitis | Small molecule | Gastrointestinal |Palatin Technologies, Inc.|Last Updated: Mar 5, 2025

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical trial landscape

PL8177 · 1 trial · 4 indications

Phase 2 1
NCT05466890Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)Ulcerative Colitis
ACTIVE NOT_RECRUITING16 Analytics
PHASE2ACTIVE NOT_RECRUITING
Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)
Ulcerative Colitis
NCT0546689016
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of PL8177 compared to placebo in patients with active UC.
Baseline through Study Completion (Week 12).

Adverse events (AEs) will be collected from the time of signing the informed consent form (ICF). All subjects who are randomized will be monitored for AEs until the time they leave the study.

To compare the proportion of subjects achieving Mayo Endoscopic Subscore of ≤ 1 point (0 or 1) between PL8177 and placebo after 8 weeks of treatment.
Time Frame: Mayo Endoscopic Subscore will be evaluated at Week 8.

Efficacy will be determined through the use of the Mayo Endoscopic Subscore.

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PL8177EXPERIMENTALPL8177 will be given orally and daily from baseline until end of study.
PlaceboPLACEBO_COMPARATORApproximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.
Interventions
NameTypeDescription
PL8177 PlaceboDRUGApproximately 1/4 of randomized patients will receive matching placebo as means of comparison to active treatment PL8177.
PL8177DRUGApproximately 3/4 of randomized patients will receive active PL8177.
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Age ≥18 to ≤75 years of age at Screening. * Has a history of UC diagnosis prior to screening; confirmed by endoscopic and histologic evidence in the subject chart. If the historical evidence is not available, then endoscopic and histologic evidence can be confirmed during the ...

Countries:United States
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Competitive Landscape -Ulcerative Colitis 92 trials
CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY8PHASE3Duvakitug
Eli Lilly and CompanyLLY8PHASE3Mirikizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK11PHASE3Vedolizumab
Johnson & JohnsonJNJ13PHASE3Ustekinumab
AbbVie, Inc.ABBV14PHASE3Upadacitinib
Merck & Co., Inc.MRK3PHASE3Tulisokibart
Pfizer Inc.PFE8PHASE3Etrasimod
Gilead Sciences, Inc.GILD3PHASE3Filgotinib
Abivax SA Sponsored ADRABVX2PHASE3ABX464
Bristol-Myers Squibb CompanyBMY5PHASE2Ozanimod
Spyre Therapeutics, IncSYRE1PHASE2SPY001, SPY002, SPY003
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Palatin Technologies, Inc.PTN1PHASE2PL8177
GSK plc Sponsored ADRGSK1PHASE1GSK4528287
Xencor, Inc.XNCR1PHASE1XmAb942
Sunshine Biopharma IncorporatedSBFM1PHASE2627
Amgen Inc.AMGN1N/AUndisclosed
TScan Therapeutics, Inc.TCRX1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05466890primaryCompletionDate: changed
LOWMay 24, 2026NCT05466890studyFirstPostDate: changed