BridgeMD
A Phase 3 study to assess efficacy, safety and tolerability of remibrutinib in adult and adolescent patients with moderate to severe hidradenitis suppurativa
EU CTIS ID: 2024-513282-39-00
What this study is testing
To demonstrate the efficacy of remibrutinib compared to placebo with respect to HiSCR50 after 16 weeks of treatment
- Therapeutic confirmatory (Phase III)
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
- Signed informed consent must be obtained prior to participation in the study. For participants aged ≥ 12 to < 18 years: parent’s or legal guardian’s signed written informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
- Male and female participants ≥ 12 years of age at the time of signing of the informed consent forms.
- Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
- Participants with moderate to severe HS at baseline defined as: • A total of at least 5 AN, i.e. abscesses and/or inflammatory nodules AND • Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)
You likely can't join if
- Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
- History of hypersensitivity to any of the study drug constituents.
- Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility.
- History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment
- Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.
- Any active skin disease or conditions that may interfere with the assessment of HS.
See the full eligibility criteria
Who can join
- Signed informed consent must be obtained prior to participation in the study. For participants aged ≥ 12 to < 18 years: parent’s or legal guardian’s signed written informed consent and child’s assent, if appropriate, must be obtained before any assessment is performed. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
- Male and female participants ≥ 12 years of age at the time of signing of the informed consent forms.
- Diagnosis of Hidradenitis Suppurativa (HS) based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
- Participants with moderate to severe HS at baseline defined as: • A total of at least 5 AN, i.e. abscesses and/or inflammatory nodules AND • Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae)
What rules you out
- Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
- History of hypersensitivity to any of the study drug constituents.
- Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the trial as per investigator's assessment. These infectious diseases include and are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected Human Immunodeficiency Virus (HIV) infection. Should it be required by local regulations and/or considered appropriate by the investigator, an HIV test can be performed to confirm eligibility.
- History of live attenuated vaccine administration within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment
- Major surgery within 8 weeks prior to screening or planned surgery for the duration of the study.
- Any active skin disease or conditions that may interfere with the assessment of HS.
- Previous exposure to remibrutinib or other BTK inhibitors.
- Use of other investigational drugs within 5 half-lives, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- Significant bleeding risk or coagulation disorders
- History of gastrointestinal bleeding.
- Requirement for anti-platelet (except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d) or anti-coagulant medication.
- History or current hepatic disease.
- Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- South Africa
- Switzerland
- Canada
- China
- Taiwan
- Malaysia
- Argentina
- Mexico
- Colombia
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, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; South Africa; Switzerland; Canada; China and 5 more location(s). 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.