Hidradenitis SuppurativaANIMA-RNCT06517732
Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 19 sites in Russia.
Trial summary
ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Secukinumab
- How many people
- 107 participants
- Where
- 19 sitesRussia
- Study dates
- 26 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with moderate to severe Hidradenitis Suppurativa commencing treatment with secukinumab
Who may be able to join
- Patients who provide written informed consent form (ICF) to participate in the study.
- Male and female.
- ≥ 18 years old.
- Diagnosis of moderate or severe HS (Hurley stage and IHS4).
- Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
- Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.
Who cannot join
- Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
- Participation in an ongoing clinical trial.
- Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
- Clinically significant infection exacerbation, including active tuberculosis.
- Patients with active inflammatory bowel disease (IBD).
- Age <18 years.
- Pregnancy and breastfeeding.
- Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Novartis Investigative Site
Izhevsk, 426039
Novartis Investigative Site
Kaliningrad, 236016
Novartis Investigative Site
Kaliningrad, 236029
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Kemerovo, 650025
Novartis Investigative Site
Krasnodar, 350020
Novartis Investigative Site
Moscow, 107076
Novartis Investigative Site
Moscow, 119881
Novartis Investigative Site
Moscow, 123182
Novartis Investigative Site
Moscow, 129110
Novartis Investigative Site
Nizhny Novgorod, 603950
Novartis Investigative Site
Penza, 440052
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Samara, 443079
Novartis Investigative Site
Saratov, 410028
Novartis Investigative Site
Stavropol, 355020
Novartis Investigative Site
Tula, 300053
Novartis Investigative Site
Ufa, 450010
Novartis Investigative Site
Yakutsk, 677000
About this study
Official title: Prospective, Observational, Multicenter Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation (ANIMA-R)
ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).
Read the detailed description
The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population.
The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Secukinumab
- Keywords
- Hidradenitis Suppurativa, HS, real-world data, secukinumab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabOther
This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa Receives: Other: Secukinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.
Measured: 12 months
Secondary outcomes (13)
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
Proportion of patients receiving Hidradenitis Suppurativa (HS)-specific concomitant treatments in combination with secukinumab
Measured: 12 months
Time of initiation of concomitant medication
Time of initiation of concomitant medication (before or after the initiation of secukinumab).
Measured: 12 months
Duration of treatment with concomitant medication
Duration of treatment with concomitant medication of secukinumab
Measured: 12 months
Number, type, and outcome of surgical interventions
Number, type, and outcome of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home)
Measured: 12 months
Timepoint of and reason for surgical intervention
Timepoint of and reason for surgical intervention.
Measured: 12 months
Duration of discontinuation/pause of secukinumab treatment before surgery
Duration of discontinuation/pause of secukinumab treatment before surgery
Measured: 12 months
Duration of discontinuation/pause of secukinumab treatment after surgery
Duration of discontinuation/pause of secukinumab treatment after surgery
Measured: 12 months
Surgery outcome
Surgery outcome by type of wound healing, pain relief and discontinuation or continuation of secukinumab.
Measured: 12 months
Outcome of surgery and adverse events stratified by secukinumab management
Outcome of surgery (healing, pain relief) and adverse events (i.e., infections) stratified by secukinumab management (continuation or discontinuation).
Measured: 12 months
Predictors of treatment response
Listing of predictors of treatment response
Measured: 12 months
Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)
The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.
Measured: Month 6, month 12
Lesion spread
Lesion spread (defined as total abscess and inflammatory nodule count (AN) or draining fistula in a body region not seen at baseline) assessed by number, type, and localization of HS lesions
Measured: Baseline, month 6, month 12
Mean change of nodule count
Mean reduction of nodule count
Measured: Month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start26 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517732
- Sponsor's protocol ID
- CAIN457MRU01
- Acronym
- ANIMA-R
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Multicenter Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) in Routine Clinical Practice in the Russian Federation (ANIMA-R)
- ClinicalTrials.gov ID
- NCT06517732
- Acronym / sponsor ID
- ANIMA-R / CAIN457MRU01
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, HS, real-world data, secukinumab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).
Detailed description
The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population.
The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | – | Other: SecukinumabPatients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderate to severe Hidradenitis Suppurativa commencing treatment with secukinumab
Key inclusion criteria (6 listed)
- Patients who provide written informed consent form (ICF) to participate in the study.
- Male and female.
- ≥ 18 years old.
- Diagnosis of moderate or severe HS (Hurley stage and IHS4).
- Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
Key exclusion criteria (8 listed)
- Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
- Participation in an ongoing clinical trial.
- Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
- Clinically significant infection exacerbation, including active tuberculosis.
- Patients with active inflammatory bowel disease (IBD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecukinumabThis is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement. | Other | Secukinumab |
Primary outcome
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
Time frame: 12 months
The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.
13 secondary outcomes
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
Time frame: 12 months
Time of initiation of concomitant medication
Time frame: 12 months
Duration of treatment with concomitant medication
Time frame: 12 months
Number, type, and outcome of surgical interventions
Time frame: 12 months
Timepoint of and reason for surgical intervention
Time frame: 12 months
Duration of discontinuation/pause of secukinumab treatment before surgery
Time frame: 12 months
Duration of discontinuation/pause of secukinumab treatment after surgery
Time frame: 12 months
Surgery outcome
Time frame: 12 months
Outcome of surgery and adverse events stratified by secukinumab management
Time frame: 12 months
Predictors of treatment response
Time frame: 12 months
Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)
Time frame: Month 6, month 12
Lesion spread
Time frame: Baseline, month 6, month 12
Mean change of nodule count
Time frame: Month 6, month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa, run by Novartis Pharmaceuticals at 19 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.