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Proof of concept study to assess the efficacy and safety of Danicopan (factor D inhibitor) in adult patients with chronic spontaneous urticaria resistant to H1-antihistamine treatment (DANICSU).
EU CTIS ID: 2024-512386-14-00
What this study is testing
To assess the role of a complement Factor D inhibitor, Danicopan, by comparing the change in Urticaria Activity Score UAS7 from baseline (week 1, V1) to the end of the open label treatment phase (week 17, V5) in adult CSU patients exhibiting low total IgE (≤40 kU/l) and in patients with high total IgE levels (>40 kU/l).
- Therapeutic exploratory (Phase II)
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
- Diagnosis of chronic spontaneous urticaria for >6 months
- Patient is ≥ 18 years of age
- Patient is diagnosed with moderate to severe CSU which is refractory to standard of care treatment at the time of enrollment, as defined by the following: o presence of itch and hives for ≥6 consecutive weeks at any time prior to enrollment despite concurrent use of H1- antihistamines o Urticaria activity score (UAS7; range 0-42) ≥ 16, in the week prior to stratification (Day 1)
- Complete vaccination against Neisseria meningitidis within 3 years prior to, or willingness to receive vaccinations or boosters against each serotype (MenACWY, MenB) as described in chapter 5.6.7 of the study protocol
You likely can't join if
- Patients whose urticaria is solely due to inducible urticaria
- Hypersensitivity to the active substance or to any of the excipients present in the danicopan formulation
- Participants with unresolved N meningitidis infection
- History of N. meningitidis infection
- Other diseases with symptoms of urticaria or angioedema
- Any other skin disease associated with chronic itching that might confound the study evaluations and results
See the full eligibility criteria
- Diagnosis of chronic spontaneous urticaria for >6 months
- Patient is ≥ 18 years of age
- Patient is diagnosed with moderate to severe CSU which is refractory to standard of care treatment at the time of enrollment, as defined by the following: o presence of itch and hives for ≥6 consecutive weeks at any time prior to enrollment despite concurrent use of H1- antihistamines o Urticaria activity score (UAS7; range 0-42) ≥ 16, in the week prior to stratification (Day 1)
- Complete vaccination against Neisseria meningitidis within 3 years prior to, or willingness to receive vaccinations or boosters against each serotype (MenACWY, MenB) as described in chapter 5.6.7 of the study protocol
- Patients whose urticaria is solely due to inducible urticaria
- Hypersensitivity to the active substance or to any of the excipients present in the danicopan formulation
- Participants with unresolved N meningitidis infection
- History of N. meningitidis infection
- Other diseases with symptoms of urticaria or angioedema
- Any other skin disease associated with chronic itching that might confound the study evaluations and results
- Participation in other clinical trials, specifically with investigational non-biologics within the previous 30 days or reception of biologics and intravitreal treatments in the previous 3 months
- Other treatments for CSU (e.g., systemic corticosteroids or other immunosuppressive medication) within specified timelines
The study team makes the final eligibility decision.
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.
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.