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The Effectiveness and Safety of Early Intervention with Maintenance dosage of Upadacitinib in mild active Ulcerative Colitis

The Effectiveness and Safety of Early Intervention with Maintenance dosage of Upadacitinib in mild active Ulcerative Colitis: A single center, open label, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078576
Enrollment
Unknown
Registered
2023-12-13
Start date
2023-12-13
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

ulcerative colitis

Interventions

Treatment group:sufficient mesalazine (= 3 grams per day) plus upadacitinib 15mg qd
Control group:sufficient mesalazine (= 3 grams per day) / sufficient mesalazine (= 3 grams per day) plus local suppositories or enemas

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)Age from 18 to 75; 2)Diagnosed for UC at least 6 months with sufficient mesalazine (= 3 grams per day) for at least 8 weeks, still experiencing diarrhea or bloody stools; 3)Mild active UC patients who meet SFS = 2 points and RBS = 1 point; 4)Tolerate to colonoscopy, participate the study voluntarily and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1)Chronic infectious diseases, including active tuberculosis, herpes zoster, clostridium difficile, hepatitis B virus, hepatitis C virus or other pathogenic microorganisms; 2)Those who are using glucocorticoids, biological agents, immunosuppressants or Chinese herbal medicine/traditional Chinese medicines which preparations with immune regulation in combination; 3)Patients with systemic symptoms such as fever, obvious fatigue, and loss of appetite; 4)Patients with colonic tumors or moderate to severe dysplasia discovered by colonoscopy and confirmed by pathology; 5)Individuals with tumors (not including those who have previously been cured of tumors) 6)Individuals with coagulation dysfunction or thromboembolic diseases (acute myocardial infarction, cerebral infarction/embolism, pulmonary embolism, or other thromboembolic conditions that occur within 6 months), liver and kidney dysfunction, and severe cardiovascular and pulmonary diseases; 7)Individuals with immunodeficiency or human immunodeficiency virus infection; 8)Pregnant and breast-feeding women; 9)Individuals without legal capacity or those with medical or ethical reasons affect the continuation of research; 10)Individuals who are not suitable for participation in this study by researcher's judgement.

Design outcomes

Primary

MeasureTime frame
Clinical remission rate;

Secondary

MeasureTime frame
mucosal healing rate;histological healing rate;fecal calprotectin;fecal occult blood;

Countries

China

Contacts

Public ContactTian yu

Peking University First Hospital

tianyu@medmail.com.cn+86 158 1032 7243

Outcome results

None listed

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