Early treatment with ustekinumab and mucosalhealing in ulcerative colitis after clinicalbut non endoscopicremission with steroids

Mucosal healing after systemic steroid therapy by early treatment with ustekinumab in moderate-to-severe ulcerative colitis: an open-label prospective pilot study - MUcosal healing after Steroids 2020 (MuST 2020)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001984-25-IT

Enrollment

Registered

2022-01-27

Start date

2022-08-09

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Trade Name: STELARA - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML Product Name: USTEKINUMAB Produc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 and >= 70 years; Diagnosis of ulcerative colitis according to International guidelines;Clinical but not endoscopic remission to a recent treatment with steroids for moderate-severe active disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Active systemic or severe local bacteric or fungal infections; Active tubercular disease of latent tubercular infection without prophylactic treatment; Toxic megacolon; Intestinalperforation; Malignancy or a history of malignancies within 5 years before the inclusion; Abnormal bone marrow function, as defined by neutrophils <1,5 x 103/¿l, CD4+-lymphocytes < 200 x 103/¿l, platelets < 50 x 103/¿l; Pregnant or lactating women;

Design outcomes

Primary

Measure	Time frame
Main Objective: --;Secondary Objective: --;Primary end point(s): Proportion of patients in endoscopic remission at 54 weeks;Timepoint(s) of evaluation of this end point: 54 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): 1. proportion of patients in endoscopic remission at 8 weeks, without intercurrent clinical relapse 2. proportion of patients in clinical remission at 8 weeks 3. proportion of patients with histologicalremissionat 8 or 54 weeks 4. proportion of patients with clinical relapse within 54 weeks 5. proportion of patientsdevelopingsteroid dependance within 54 weeks 6. proportion of patientstreated with colectomywithin 54 weeks 7. proportion of patientsrequiringhospitalization for active UC within 54 weeks;Timepoint(s) of evaluation of this end point: 8 or 54 weeks	—

Measure

Time frame

Secondary end point(s): 1. proportion of patients in endoscopic remission at 8 weeks, without intercurrent clinical relapse 2. proportion of patients in clinical remission at 8 weeks 3. proportion of patients with histologicalremissionat 8 or 54 weeks 4. proportion of patients with clinical relapse within 54 weeks 5. proportion of patientsdevelopingsteroid dependance within 54 weeks 6. proportion of patientstreated with colectomywithin 54 weeks 7. proportion of patientsrequiringhospitalization for active UC within 54 weeks;Timepoint(s) of evaluation of this end point: 8 or 54 weeks

—

Countries

Italy

Contacts

Public ContactSegreteria Amministrativa del Comit

Asst Sette Laghi

comitato.etico@asst-settelaghi.it0332393631

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026