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oral Tofacitinib compared with oral Cyclosporine A for the treatment of refractory chronic spontaneous urticaria

Safety and efficacy of oral tofacitinib compared with oral cyclosporin A in cases of refractory chronic spontaneous urticaria, an open label clinical trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091047
Enrollment
158
Registered
2025-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: L509- Urticaria, unspecified

Interventions

Intervention1: Oral tofacitinib: 5 mg oral tofacitinib twice daily daily for a period of maximum 6 months or till the time UAS7 equals 0 Control Intervention1: oral cyclosporine A: dose dependent oral

Sponsors

Government Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to participate in the study by giving written informed consent Patients with age ranging between 18 to 60 years having CSU upto or more than 6 months resistant to treatment after a fourfold dosage of second-generation antihistamines for upto4 weeks Patients with UAS7 score upto or more than 16 at baseline

Exclusion criteria

Exclusion criteria: concurrent immunosuppressive use positive autologous serum skin test acute urticaria specific comorbidities or hypersensitivity to the study drugs

Design outcomes

Primary

MeasureTime frame
UAS7 score reduction from baseline cut-off upto or more than 16Timepoint: Month 0 1 2 3 4 5 6 9—

Secondary

MeasureTime frame
Urticaria control testTimepoint: month 0 month 9;Dermatology Life Quality IndexTimepoint: month 0 month 9;Patient Global Impression of changeTimepoint: month 0 month 9;incidence and severity of any adverse eventsTimepoint: month 0 1 2 3 4 5 6 9—

Countries

India

Contacts

Public ContactDr Bushra Iqbal Khan

Government Medical College and Hospital Nagpur

dr.bushraiqbalkhan@gmail.com8698812588

Outcome results

None listed

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