← Back to Search

Monoclonal Antibodies

sarilumab for Systemic Mastocytosis

Phase 2
Waitlist Available
Led By Hirsh D Komarow, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 and week 16 for bone marrow and day 0, week 16 and week 28 for d816v allelic frequency
Awards & highlights

Study Summary

This trial is testing if the drug sarilumab is safe and effective for people with indolent systemic mastocytosis.

Eligible Conditions
  • Indolent Systemic Mastocytosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 and week 16 for bone marrow and day 0, week 16 and week 28 for d816v allelic frequency
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 and week 16 for bone marrow and day 0, week 16 and week 28 for d816v allelic frequency for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and Severity of AE's
Mastocytosis
Secondary outcome measures
Questionnaires MC-Qol, MSAS, SCORMA, MQLQ, MSAF
Reductions in use of medicines and reduction in serum Tryptase
mast cells in bone marrow and allelic frequency of D816V

Trial Design

2Treatment groups
Active Control
Group I: placeboActive Control1 Intervention
8 SC injections of placebo
Group II: sarilumabActive Control1 Intervention
8 SC injections of 200 mg/1.14 ml of sarilumab over 16 weeks

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,679 Total Patients Enrolled
Hirsh D Komarow, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
3 Previous Clinical Trials
842 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the regulatory status of sarilumab?

"Sarilumab's safety is assigned a score of 2 on our team at Power's scale due to the lack of efficacy data, although there has been some research indicating that it can be safe."

Answered by AI

Is the upper age limit for inclusion in this experiment greater than 20 years?

"Those aged 18 or over, and below 75 years of age are eligible to participate in this research trial."

Answered by AI

Are there any accounts of research conducted focusing on sarilumab?

"Currently, there are 7 ongoing clinical trials of sarilumab with 2 in the final stages. While many testing sites are located in Omaha, Nebraska, 465 different medical facilities across the world offer this trial."

Answered by AI

What is the current intake capacity for this clinical trial?

"Affirmative. Clinicaltrial.gov's records demonstrate that this medical study is still looking for participants to join their trial, which was first published on June 19th 2019 and amended most recently on October 29th 2022. 60 individuals are required from a single clinical centre."

Answered by AI

Are there any opportunities to participate in this experiment at present?

"Indeed, the clinicaltrial.gov website confirms that this study is actively recruiting participants. It was originally posted on June 19th 2019 and last updated on October 29th 2022 with a goal of 60 patients at 1 site."

Answered by AI

What qualifications must a person possess in order to participate in this research?

"This investigation requires 60 participants suffering from systemic mastocytosis aged 18 to 75. The main requirements for enrolment are: consenting to storage of biological samples, a minimum score on the MC-QoL questionnaire indicating that they were affected by all questions, and being within the specified age range."

Answered by AI

What are the fundamental aims of this experiment?

"The primary purpose of this clinical trial, assessed over a period spanning 0 days to 28 weeks, is to examine the impact on patient quality-of-life through the analysis of Mastocytosis Quality of Life Questionnaire (MC-Q0L). Secondary objectives are focused upon assessing changes in medication use and serum Tryptase levels; investigating mast cells within bone marrow, D816V allelic frequency using PCR; as well as evaluating QoL via MC-Qol, SCORMA indexing for mastocytosis symptoms, MSAS scales and MQLQ/MSAF assessment forms."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis
2019. "Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03770273.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top