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Study QEL-005-CLN-01. Phase I/II study of QEL-005 in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA).
EU CTIS ID: 2025-523971-46-00
What this study is testing
To determine the safety and tolerability of a single dose of QEL-005.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be at least 18 years of age at the time of signing the informed consent.
- Specific inclusion criteria for participants with systemic sclerosis (SSc) only 1. Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) as per the 2013 ACR-EULAR criteria. 2. Serologically positive for antinuclear antibodies 3. Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs). 4. Skin involvement with a total modified Rodnan Skin Score of at least 15 Evidence of lung fibrosis based on imaging or pulmonary function testing 5. Evidence of active disease based on a validated SSc activity assessment
- Up to date vaccination schedule as per local guidance
- Adequate haematological, liver and renal function as assessed by the Investigator according to local laboratory tests
- 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, that, in the Investigator's opinion, may impact participant safety or the participant’s ability to undergo study procedures.
- 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 (TB), syphilis or HIV.
- Participants with clinically significant cardiac dysfunction or pulmonary disease
See the full eligibility criteria
- Participants must be at least 18 years of age at the time of signing the informed consent.
- Specific inclusion criteria for participants with systemic sclerosis (SSc) only 1. Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) as per the 2013 ACR-EULAR criteria. 2. Serologically positive for antinuclear antibodies 3. Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs). 4. Skin involvement with a total modified Rodnan Skin Score of at least 15 Evidence of lung fibrosis based on imaging or pulmonary function testing 5. Evidence of active disease based on a validated SSc activity assessment
- Up to date vaccination schedule as per local guidance
- Adequate haematological, liver and renal function as assessed by the Investigator according to local laboratory tests
- 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 inclusion criteria for participants with difficult to treat rheumatoid arthritis (D2TRA) only: 1. Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria 2. Diagnosis of D2TRA per 2021 EULAR criteria 3. Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA. 4. Evidence of inflammation in target joints used for the DAS28 CRP assessment
- Presence of a significant medical condition(s), or clinically significant laboratory abnormality, that, in the Investigator's opinion, may impact participant safety or the participant’s ability to undergo study procedures.
- 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 (TB), syphilis or HIV.
- Participants with clinically significant cardiac dysfunction or pulmonary disease
- History of malignancy within the past 5 years
- Receiving prohibited medications that cannot be stopped at screening
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.