Hidradenitis SuppurativaPhase 1NCT07855276
A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HS
A Phase 1 study testing LOU064 in people with Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study aims to better understand how Bruton's tyrosine kinase (BTK) inhibition with remibrutinib works in hidradenitis suppurativa (HS), a complex inflammatory disease with different types of lesions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- LOU064
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 18 Jan 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants ≥ 18 years to 65 years of age at the time of signing of the informed consent forms (ICF).
- Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to Day 1.
- Participants with moderate to severe HS at Day 1 defined as:
- A total of at least 5 abscesses and inflammatory nodules (AN), i.e. abscesses and/or inflammatory nodules
- Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae).
- At least 1 chronic lesion, which is defined by the presence of a draining tunnel and further meeting biopsy criteria as defined in the laboratory manual.
Who cannot join
- Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
- 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.
- Previous exposure to remibrutinib or other BTK inhibitors.
- Previous exposure to investigational Janus Kinase (JAK) inhibitors.
- Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical 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.
- Significant bleeding risk or coagulation disorders.
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- History or current hepatic disease (moderate to severe Hepatic Impairment (HI) as per Child-Pugh classification), including but not limited to, acute or chronic hepatitis (with the exception of Hepatitis B or C - see respective exclusion criterion above), cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at Screening.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). WOCBP are excluded unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 7 days after stopping study treatment. Highly effective contraception methods.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States1 site, 1 recruiting
- Recruiting
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124
Caroline Matyas, cmatyas@apexskin.com
Jorge Garcia-Zuazaga
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Mechanistic Study in Adult Patients With Moderate to Severe Hidradenitis Suppurativa to Explore the Effects of Remibrutinib on Tissue Level
This study aims to better understand how Bruton's tyrosine kinase (BTK) inhibition with remibrutinib works in hidradenitis suppurativa (HS), a complex inflammatory disease with different types of lesions.
Read the detailed description
This is a Phase 1, interventional, multicenter, randomized, double-blind, parallel group, placebo-controlled, exploratory study to evaluate the MoA of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa.
The total duration of the study is 24 weeks and consists of Screening (up to 4 weeks), Treatment (16 weeks, double-blind treatment with remibrutinib or placebo), and Follow-up (treatment-free follow-up for 4 weeks) periods.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- LOU064, Placebo
- Keywords
- BTK inhibitor, hidradenitis suppurativa, sHiSCR, remibrutinib
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOU064Drug
Also called remibrutinib
Remibrutinib
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| LOU064 | Experimental | Participants will receive remibrutinib during treatment period. Receives: Drug: LOU064 |
| Placebo | Placebo comparator | Participants will receive matching placebo during treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold change from baseline in auto-antibodies
To evaluate the effect of remibrutinib compared with placebo.
Measured: Baseline, Week 16
Secondary outcomes (1)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs.
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion21 Dec 2027 (estimated)
- Study completion18 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855276
- Sponsor's protocol ID
- CLOU064J12101
- Other IDs
- 2025-524222-18-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No