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NOT YET RECRUITING
NCT07517185
PHASE2

The HIt HArd and hiT Early in Multiple Sclerosis Trial

Sponsor: Uppsala University

View on ClinicalTrials.gov

Summary

The HiHat trial is a Phase 2 study aimed at evaluating the safety and feasibility of sequential treatment with rituximab and cladribine in patients with relapsing-remitting multiple sclerosis (RRMS). The study follows a prospective, open-label, single-arm design, with 60 RRMS patients receiving both treatments in a controlled regimen: two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart. Participants are monitored over 24 months through clinical assessments, MRI, and biomarker analyses. The primary objective is to evaluate whether the rate of serious adverse events (SAE) is acceptably low. Secondary objectives include assessing impacts on MRI lesion count, relapse rates, disability progression, quality of life, and safety.

Official title: The HIt HArd and hiT Early in Multiple Sclerosis Trial - HiHat Trial A Phase 2 Study of Sequential Treatment With Rituximab and Cladribine for Relapsing-remitting Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04-15

Completion Date

2030-12-31

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Sequential treatment with rituximab and cladribine

Two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart.

Locations (4)

Falu Lasarett, Neurologen

Falun, Sweden

Gävle sjukhus, Neurologmottagningen

Gävle, Sweden

Centralsjukhuset Karlstad, Neurologi och Rehabiliteringskliniken

Karlstad, Sweden

Uppsala University Hospital

Uppsala, Sweden