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
New trial tests sequential rituximab and cladribine for early MS
Plain English Summary
The HIt HArd and hiT Early in Multiple Sclerosis Trial is a Phase 2 clinical trial sponsored by Uppsala University studying Relapsing-remitting Multiple Sclerosis. This trial tests a combination of two medications, rituximab and cladribine, given one after the other, to treat relapsing-remitting multiple sclerosis (RRMS). It is for adults aged 18-50 with RRMS who have shown recent disease activity. Participants will receive two rounds of rituximab followed by two rounds of cladribine over a period of time, and will be monitored for 24 months. Alternative treatments for RRMS include other disease-modifying therapies, some of which are also B-cell depleting. The trial aims to enroll 60 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are diagnosed with RRMS and have had a relapse or new MRI activity in the past year. You must be between 18 and 50 years old and have had MS for 10 years or less. You cannot join if you have progressive MS, have previously received rituximab or cladribine, are pregnant or breastfeeding, or have severe heart, kidney, or other serious health conditions. This trial is studying Relapsing-remitting Multiple Sclerosis, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if this sequential treatment causes a low number of serious side effects, meaning it is likely safe for patients to try. The specific primary outcome measures are: Treatment-related Serious Adverse Events (From start of treatment until end of follow-up at 2 years.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial aims to find a potentially more effective way to manage early, active relapsing-remitting MS by using two powerful B-cell depleting therapies sequentially, addressing a need for optimized t Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Relapsing-remitting Multiple Sclerosis, where improved treatment options are needed.
Investor Insight
This trial explores a novel sequential treatment approach for a common form of MS, potentially offering a new option in a competitive market for MS therapies. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of rituximab and cladribine, and how this sequential approach differs from other treatments. Participation involves receiving infusions of rituximab and then taking oral cladribine, followed by regular check-ups, MRIs, and tests for two years. You will need to use effective contraception during treatment and for a year after. The trial is being conducted at 4 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 60 participants
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.
Primary Outcomes
- Treatment-related Serious Adverse Events (From start of treatment until end of follow-up at 2 years.)
Secondary Outcomes
- Magnetic Resonance Imaging (MRI) lesions (The first scan made after the treatment course has been completed (week 12) will be compared with the scan at 2 years to determine if new lesions have occurred.)
- Relapses (From start of treatment until the end of follow-up at 2 years.)
- Disability (EDSS at baseline will be compared with EDSS at end of follow-up at 2 years.)
- Symbol Digit Modalities Test (SDMT) (SDMT at baseline is compared with SDMT at end of follow-up at 2 years.)
- Quality of life (physical) measured by MSIS-29 (Multiple Sclerosis Impact Scale) (Baseline compared with end of follow-up at 2 years.)
Full Eligibility Criteria
Inclusion Criteria: * Diagnosis of RRMS according to the 2017 revised McDonald criteria, * With disease activity within the preceding year in the form of: a clinical relapse, and/or evidence of ≥2 T2 lesions on MRI scan, and or presence of gadolinium enhancing lesions on an MRI scan, * Age 18 - 50 years (inclusive) of age, * Disease duration ≤10 years (since MS diagnosis), * EDSS 0 - 5.5 (inclusive), * Signed informed consent. Exclusion Criteria: * Diagnosis of progressive MS, * Previous use of rituximab (or any other B-cell depleting monoclonal antibody) and/or cladribine, * Pregnant or lactating women, * Unwilling to use contraception during the treatment period and the first year after completing the treatment course, * Patients having contraindication for or otherwise not compliant with MRI investigations, * Simultaneous treatment with other immunosuppressive drugs, * Infection with human immunodeficiency virus (HIV), * Active, severe infections (e.g. hepatitis or tuberculosis), * Severe cardiac disorder, * Moderate or severe renal impairment (eGFR \<60). * Active malignancy, * No prior exposure to varicella virus, * Vaccination within 4 weeks of first dose of study medication, * Severe psychiatric condition.
Trial Locations
- Falu Lasarett, Neurologen, Falun, Sweden
- Gävle sjukhus, Neurologmottagningen, Gävle, Sweden
- Centralsjukhuset Karlstad, Neurologi och Rehabiliteringskliniken, Karlstad, Sweden
- Uppsala University Hospital, Uppsala, Sweden
Frequently Asked Questions
What is clinical trial NCT07517185?
NCT07517185 is a Phase 2 INTERVENTIONAL study titled "The HIt HArd and hiT Early in Multiple Sclerosis Trial." It is currently not yet recruiting and is sponsored by Uppsala University. The trial targets enrollment of 60 participants.
What conditions does NCT07517185 study?
This trial investigates treatments for Relapsing-remitting Multiple Sclerosis. The primary condition under study is Relapsing-remitting Multiple Sclerosis.
What treatments are being tested in NCT07517185?
The interventions being studied include: Sequential treatment with rituximab and cladribine (DRUG). 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.
What does Phase 2 mean for NCT07517185?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07517185?
This trial is currently "Not Yet Recruiting." It started on 2026-04-15. The estimated completion date is 2030-12-31.
Who is sponsoring NCT07517185?
NCT07517185 is sponsored by Uppsala University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07517185?
The trial aims to enroll 60 participants. The trial has not yet started recruiting.
How is NCT07517185 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07517185?
The primary outcome measures are: Treatment-related Serious Adverse Events (From start of treatment until end of follow-up at 2 years.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07517185 being conducted?
This trial is being conducted at 4 sites, including Falun; Gävle; Karlstad; Uppsala (Sweden).
Where can I find official information about NCT07517185?
The official record for NCT07517185 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07517185. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07517185 testing in simple terms?
This trial tests a combination of two medications, rituximab and cladribine, given one after the other, to treat relapsing-remitting multiple sclerosis (RRMS). It is for adults aged 18-50 with RRMS who have shown recent disease activity.
Why is this trial significant?
This trial aims to find a potentially more effective way to manage early, active relapsing-remitting MS by using two powerful B-cell depleting therapies sequentially, addressing a need for optimized t
What are the potential risks of participating in NCT07517185?
The most significant risk is the potential for serious side effects from the medications, including severe infections. Other potential side effects include reactions to the infusions, low white blood cell counts, and possible effects on the heart or kidneys. There is also a risk of developing a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07517185?
Ask your doctor about the specific risks and benefits of rituximab and cladribine, and how this sequential approach differs from other treatments. Participation involves receiving infusions of rituximab and then taking oral cladribine, followed by regular check-ups, MRIs, and tests for two years. You will need to use effective contraception during treatment and for a year after. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07517185 signal from an investment perspective?
This trial explores a novel sequential treatment approach for a common form of MS, potentially offering a new option in a competitive market for MS therapies. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive two rounds of rituximab followed by two rounds of cladribine over a period of time, and will be monitored for 24 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.