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New treatment option for Diffuse Cutaneous Systemic Sclerosis
Official title Controlling Hyperactive Immunity With Long-lived Lymphocytes
ClinicalTrials.gov ID: NCT07473154
What this study is testing
What is QEL-005?
QEL-005 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for diffuse cutaneous systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a Phase 1/2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be at least 18 years of age at the time of signing the informed consent.
- Up to date vaccination status and no planned vaccinations for post 3 months infusion
- Adequate haematological, liver and renal function
- Willing to undergo annual influenza vaccination
- Willing to enter a 15-year follow-up
You likely can't join if
- Presence of a significant medical condition(s), or clinically significant laboratory abnormality
- History or concern of autoimmune diseases other than those under study
- Active infection, or recurrent chronic infection requiring intervention
- Immunodeficiency or receiving immunoglobulin replacement therapy
- Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV
- Clinically significant cardiac dysfunction or severe pulmonary impairment
See the full eligibility criteria
- Participants must be at least 18 years of age at the time of signing the informed consent.
- Up to date vaccination status and no planned vaccinations for post 3 months infusion
- Adequate haematological, liver and renal function
- Willing to undergo annual influenza vaccination
- Willing to enter a 15-year follow-up
- Eastern Cooperative Oncology Group (ECOG) performance status grade \< 3
- Able and willing to use a highly effective method of contraception
- Stable dose of steroid prior to screening Specific for participants with difficult to treat rheumatoid Arthritis (D2TRA) only:
- Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria
- Diagnosis of D2TRA per 2021 EULAR criteria
- Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA
- Evidence of inflammation in target joints used for the DAS28 CRP assessment Specific for participants with diffuse cutaneous systemic sclerosis (dcSSc) only:
- Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria
- Serologically positive for antinuclear antibodies
- Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs).
- Skin involvement with a total modified Rodnan Skin Score of at least 15
- Evidence of lung fibrosis based on imaging or pulmonary function testing
- Evidence of active disease based on a validated SSc activity assessment
- Presence of a significant medical condition(s), or clinically significant laboratory abnormality
- History or concern of autoimmune diseases other than those under study
- Active infection, or recurrent chronic infection requiring intervention
- Immunodeficiency or receiving immunoglobulin replacement therapy
- Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV
- Clinically significant cardiac dysfunction or severe pulmonary impairment
- Use of investigational agents within a pre-defined period prior to study screening
- Received a previous cell therapy
- Received certain B cell related experimental therapies in a clinical trial with the past year
- Any solid organ, bone marrow or stem cell transplant
- History of malignancy in the past 5 years
- Receiving prohibited medication that cannot be stopped at screening
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Newcastle, United Kingdom
- Oxford, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, United Kingdom; Leeds, United Kingdom; London, United Kingdom; Newcastle, United Kingdom; Oxford, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.