Active, not recruitingObservationalNCT03765450 ↗Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative ColitisDana Jeremy LukinPIInterventionDrug: InfliximabDatesDec 2018 – Dec 2023
RecruitingInterventional · Phase 1NCT03816345 ↗A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Ashish SaxenaPIInterventionProcedure: Biospecimen Collection · Drug: Cabozantinib · Drug: Fluoropyrimidine · Biological: Ipilimumab · Biological: Nivolumab · Drug: Platinum Compound · Drug: Platinum DoubletDatesJul 2019 – Mar 2028 (est.)SponsorNational Cancer InstituteAutoimmune DiseaseCrohn DiseaseDermatomyositis+11 more
Active, not recruitingInterventional · Phase 3NCT04624230 ↗OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITISRobbyn SockolowPIInterventionDrug: tofacitinibDatesAug 2021 – Mar 2027 (est.)SponsorPfizer, Inc.Ulcerative Colitis
Active, not recruitingInterventional · Phase 4NCT04835506 ↗Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE TrialDana Jeremy LukinPIInterventionDrug: InfliximabDatesNov 2021 – Sep 2026 (est.)SponsorBeth Israel Deaconess Medical Center, Inc.Crohn DiseaseUlcerative ColitisInflammatory Bowel Diseases
RecruitingObservationalNCT04897282 ↗Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI In-vitro Diagnostics Device to Detect Treatment Response Measured by Endoscopic Healing in Moderate to Severe Ulcerative Colitis Patients Treated With Anti-TNF-a.Dana Jeremy LukinPIInterventionDiagnostic test: UCRIDatesAug 2021 – Dec 2024 (est.)SponsorGlycominds, LLCUlcerative Colitis
RecruitingInterventional · Not applicableNCT05230173 ↗Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic RemissionDana Jeremy LukinPIInterventionOther: PragmaticDatesOct 2022 – Aug 2028 (est.)SponsorUniversity of California, San DiegoUlcerative ColitisCrohn Disease
Active, not recruitingInterventional · Phase 2NCT05242484 ↗A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisEllen J ScherlPIInterventionBiological: Guselkumab · Biological: Golimumab · Biological: JNJ-78934804 · Drug: PlaceboDatesSep 2022 – May 2025SponsorJanssen Research & Development, LLCColitis, Ulcerative
Active, not recruitingInterventional · Phase 2NCT05466890 ↗Phase 2a, Double-Blind, Randomized Adaptive Design, Placebo-Controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Efficacy, PK and Biomarkers with Oral Colon Delivery PL8177 in Adult Subjects with Active Ulcerative ColitisDana Jeremy LukinPIInterventionDrug: PL8177 Placebo · Drug: PL8177DatesSep 2022 – Feb 2025SponsorPalatin Technologies, Inc.Ulcerative ColitisUlcerative Colitis AcuteUlcerative+1 more
Active, not recruitingInterventional · Phase 4NCT06095128 ↗An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative ColitisDana Jeremy LukinPIInterventionDrug: Vedolizumab · Drug: TofacitinibDatesJun 2024 – Jul 2027 (est.)SponsorTakeda Development Center Americas, Inc.Ulcerative Colitis
RecruitingInterventional · Phase 3NCT06100289 ↗An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous TherapyAliza B SolomonPIInterventionDrug: Vedolizumab IV · Drug: Vedolizumab SCDatesJan 2025 – May 2028 (est.)SponsorTakeda Development Center Americas, Inc.Ulcerative ColitisCrohn's Disease
Active, not recruitingInterventional · Phase 2NCT06109441 ↗Phase 2a, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of ALTB-268 in Subjects With Moderately to Severely Active Ulcerative Colitis Refractory to Biologic TherapyDana Jeremy LukinPIInterventionBiological: ALTB-268DatesDec 2023 – Mar 2026SponsorAltruBio, Inc.Ulcerative Colitis
Active, not recruitingInterventional · Phase 2NCT06257875 ↗A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative ColitisEllen J ScherlPIInterventionDrug: Lutikizumab · Drug: AdalimumabDatesMar 2024 – Sep 2027 (est.)SponsorAbbVie Inc.Ulcerative Colitis
RecruitingInterventional · Phase 3NCT06405087 ↗A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's DiseaseAliza B SolomonPIInterventionDrug: Vedolizumab SC · Other: No InterventionDatesOct 2025 – Aug 2030 (est.)SponsorTakeda Development Center Americas, Inc.Ulcerative ColitisCrohn's Disease
Enrolling by invitationInterventional · Not applicableNCT06560021 ↗A Randomized Trial of the Utility of Random Biopsies in Patients With Inflammatory Bowel DiseaseDana Jeremy LukinPIInterventionOther: Biopsy strategyDatesJan 2025 – Dec 2028 (est.)SponsorUniversity of PennsylvaniaInflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis
RecruitingInterventional · Phase 2NCT07012395 ↗Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative ColitisDana Jeremy LukinPIInterventionDrug: SPY001 · Drug: SPY002 · Drug: SPY003 · Other: PlaceboDatesMay 2025 – Jun 2027 (est.)SponsorSpyre Therapeutics INCUlcerative ColitisInflammatory Bowel DiseasesColitis+1 more
RecruitingInterventional · Phase 3NCT07184996 ↗A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis.Ellen J ScherlPIInterventionDrug: Duvakitug · Drug: PlaceboDatesOct 2025 – May 2028 (est.)SponsorSanofi S.A.Ulcerative Colitis
RecruitingInterventional · Phase 3NCT07185009 ↗A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative ColitisEllen J ScherlPIInterventionDrug: Duvakitug · Drug: PlaceboDatesJan 2026 – Sep 2028 (est.)SponsorSanofi S.A.Ulcerative Colitis
Active, not recruitingInterventional · Phase 3NCT07196748 ↗A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative ColitisEllen J ScherlPIInterventionDrug: Icotrokinra · Drug: PlaceboDatesOct 2025 – Jan 2028 (est.)SponsorJanssen Research & Development, LLCColitis, Ulcerative
Enrolling by invitationInterventional · Phase 2NCT07652294 ↗A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants With Inflammatory Bowel DiseaseDana Jeremy LukinPIInterventionDrug: SPY001 · Drug: SPY002 · Drug: SPY003DatesJun 2026 – Mar 2029 (est.)SponsorSpyre Therapeutics INCUlcerative ColitisInflammatory Bowel DiseasesColitis+1 more
CompletedInterventional · Phase 3NCT03283085 ↗A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)Ellen J ScherlPIInterventionDrug: 25 mg Ontamalimab · Drug: 75 mg OntamalimabDatesFeb 2018 – Dec 2023· Results postedSponsorShire Pharmaceuticals, Inc.Crohn's DiseaseUlcerative Colitis