Phase 1b Safety Study of IMSB301 in Type 1 Interferonopathies (NCT07364513) | Clinical Trial Compass
RecruitingPhase 1
Phase 1b Safety Study of IMSB301 in Type 1 Interferonopathies
Australia6 participantsStarted 2026-01-12
Plain-language summary
Open-Label Study (Phase Ib) of Type 1 Interferonopathy patients receiving IMSB301 monotherapy.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. First subject must be at least 16 years of age and weighing at least 50 kg. Remaining subjects must be at least 12 years of age and weighing at least 40 kg.
. Molecular diagnosis of one of the following:
. Aicardi-Goutières Syndrome (AGS) with mutations in TREX1, RNASEH2A, RNASEH2B, RNASEH2C, SAMHD1, LMS11, or RNU7-11, or
. Monogenic SLE with mutations in TREX1, RNASEH2A, RNASEH2B, or RNASEH2C, or
. Familial chilblain lupus (CHBL) with mutations in TREX1 or SAMHD1, or
. Neurological syndromes with mutations in ATAD3A, or
. An unnamed interferonopathy with mutations in DNASE2, or
. Coatomer Protein Complex subunit alpha (COPA) syndrome with mutations in COPA. The remaining subtypes of AGS and other type 1 interferonopathies are not eligible.
Exclusion criteria
. Presence of other significant neurological disorder that is not related to type 1 interferonopathy, brain tumor or other space-occupying lesion, or history of severe head injury.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The presence of significant concomitant disease that would, in the judgement of the Investigator, pose additional risk to the subject, interfere with the assessment of safety and tolerability, or significantly interfere with the metabolic disposition of study drug.
. BMI above 33 kg/m2 or a total body weight in excess of 130 kg.
. Have any of the following infection risks:
. Evidence of active infection during screening or on Day 1
. Symptomatic herpes zoster infection within 12 weeks prior to the screening period, or more than one episode of herpes zoster infection in the preceding two years
. Positive hepatitis B, hepatitis C, HIV or TB test at screening
. Household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB