HidradenitisPhase 2AURALIGHTNCT07812116
A Study to Investigate Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing Duvakitug in people with Hidradenitis, run by Sanofi.
Trial summary
This is a parallel, Phase 2b, 3-arm, double-blind, randomized, multicenter, multinational, placebo-controlled, dose-ranging study to evaluate the efficacy and the safety of different doses of duvakitug in adult participants with moderate to severe hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis
- What is being tested?
- Duvakitug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2026to 8 Nov 2030
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline Visit
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
- Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
- Participants must have had an inadequate response to a course of a systemic antibiotics for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics, or has a contraindication to systemic antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
- Participants must have a prior HS treatment history consistent with the following:
- For the biologic and immunosuppressive small molecule-naïve subgroup, participants must have no history of treatment with any approved or investigational biologic therapy or small molecule immunosuppressive therapy with potential efficacy for HS.
- For the biologic and immunosuppressive small molecule-experienced subgroup, participants must have a history of treatment with at least 1 biologic or immunosuppressive small molecule therapy with potential efficacy for HS.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- History of systemic hypersensitivity or anaphylaxis to any biologic therapy
- History of recurrent or recent serious infection
- Known history of or suspected significant current immunosuppression
- History of solid organ transplant or stem cell transplant.
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- History of splenectomy
- History of malignancy or suspicion of malignancy within 5 years prior to the Screening Visit (except for in situ cervical carcinoma that has been treated by surgery and completely cured, or basal cell carcinoma or squamous cell carcinoma that has been excised and completely cured)
- History within the 2 years prior to Baseline Visit of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
- Any medical or psychiatric condition which, in the opinion of the Investigator could be considered uncontrolled, unstable, or likely to progress in a clinically relevant manner and may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
- Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable, or may interfere with study assessments.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
About this study
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This is a parallel, Phase 2b, 3-arm, double-blind, randomized, multicenter, multinational, placebo-controlled, dose-ranging study to evaluate the efficacy and the safety of different doses of duvakitug in adult participants with moderate to severe hidradenitis suppurativa.
Study details include:
- The study duration will be up to 145 weeks , including a 4-week screening period, a 16-week initial double-blind treatment period, a 24-week active blinded extension period, a 96-week long-term extension period and a 5-week follow-up period.
- The treatment duration will be up to 40 weeks for the participants who will stop after the active blinded extension period and up to 136 weeks for the participants who will continue in the long-term extension period.
- The number of visits will be up to 23 for the participants who will stop after the active blinded extension period and up to 71 for the participants who will continue in the long-term extension period.
- Conditions
- Hidradenitis
- Being tested
- Duvakitug, Placebo
- Medical subject headings
- Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvakitugDrug
Also called SAR447189
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
PlaceboDrug
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Duvakitug Dose Regimen A | Experimental | Participants will receive Duvakitug dose regimen A as per protocol Receives: Drug: Duvakitug |
| Duvakitug Dose Regimen B | Experimental | Participants will receive Duvakitug dose regimen B as per protocol Receives: Drug: Duvakitug |
| Placebo | Placebo comparator | Participants will receive Duvakitug matching placebo as per protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count.
Measured: At Week 16
Secondary outcomes (10)
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count)
Measured: At Week 16
Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
Measured: From baseline to Week 16
Percentage of participants achieving Achievement of Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Hidradenitis Suppurativa Clinical Response 90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count.
Measured: At Week 16
Percent change from baseline to Week 16 in draining tunnel count
Measured: From Baseline to week 16
Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3
The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS.Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period).
Measured: From Baseline to week 16
Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
Measured: From Baseline to Week 16
Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
The Hidradenitis Suppurativa Quality of Life (HiSQoL) is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
Measured: From Baseline to Week 16
Number of participants with Treatment Emergent Adverse Events (TEAEs) Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) leading to treatment discontinuation, and TEAESIs, throughout the study
Measured: Up to End of Study (approximately 145 weeks)
Serum concentrations of duvakitug throughout the study
Measured: Up to End of Study (approximately 145 weeks)
Incidence of treatment-emergent anti-drug antibodies (ADA) against duvakitug over time
Measured: Up to End of Study (approximately 145 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start13 Oct 2026 (estimated)
- Primary completion16 Jun 2028 (estimated)
- Study completion8 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HidradenitisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812116
- Sponsor's protocol ID
- DRI24004
- Other IDs
- 2026-526166-24, U1111-1335-9652
- Acronym
- AURALIGHT
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07812116
- Acronym / sponsor ID
- AURALIGHT / DRI24004
- Conditions
- Hidradenitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Teva Branded Pharmaceutical Products R&D LLC
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 16 Jun 2028 (estimated)
- Study completion
- 8 Nov 2030 (estimated)
- First posted
- 10 Sep 2026 (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.
This is a parallel, Phase 2b, 3-arm, double-blind, randomized, multicenter, multinational, placebo-controlled, dose-ranging study to evaluate the efficacy and the safety of different doses of duvakitug in adult participants with moderate to severe hidradenitis suppurativa.
Study details include:
- The study duration will be up to 145 weeks , including a 4-week screening period, a 16-week initial double-blind treatment period, a 24-week active blinded extension period, a 96-week long-term extension period and a 5-week follow-up period.
- The treatment duration will be up to 40 weeks for the participants who will stop after the active blinded extension period and up to 136 weeks for the participants who will continue in the long-term extension period.
- The number of visits will be up to 23 for the participants who will stop after the active blinded extension period and up to 71 for the participants who will continue in the long-term extension period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duvakitug Dose Regimen A | Experimental | Drug: DuvakitugParticipants will receive Duvakitug dose regimen A as per protocol |
| Duvakitug Dose Regimen B | Experimental | Drug: DuvakitugParticipants will receive Duvakitug dose regimen B as per protocol |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Duvakitug matching placebo as per protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline Visit
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
- Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
- Participants must have had an inadequate response to a course of a systemic antibiotics for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics, or has a contraindication to systemic antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
- Participants must have a prior HS treatment history consistent with the following:
Key exclusion criteria (12 listed)
- Participants are excluded from the study if any of the following criteria apply:
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- History of systemic hypersensitivity or anaphylaxis to any biologic therapy
- History of recurrent or recent serious infection
- Known history of or suspected significant current immunosuppression
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 |
|---|---|---|
| DuvakitugAlso: SAR447189Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection | Drug | Duvakitug Dose Regimen A, Duvakitug Dose Regimen B |
| PlaceboPharmaceutical form: Solution for injection Route of administration: Subcutaneous injection | Drug | Placebo |
Primary outcome
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Time frame: At Week 16
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count.
10 secondary outcomes
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time frame: At Week 16
Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
Time frame: From baseline to Week 16
Percentage of participants achieving Achievement of Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
Time frame: At Week 16
Percent change from baseline to Week 16 in draining tunnel count
Time frame: From Baseline to week 16
Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3
Time frame: From Baseline to week 16
Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
Time frame: From Baseline to Week 16
Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
Time frame: From Baseline to Week 16
Number of participants with Treatment Emergent Adverse Events (TEAEs) Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) leading to treatment discontinuation, and TEAESIs, throughout the study
Time frame: Up to End of Study (approximately 145 weeks)
Serum concentrations of duvakitug throughout the study
Time frame: Up to End of Study (approximately 145 weeks)
Incidence of treatment-emergent anti-drug antibodies (ADA) against duvakitug over time
Time frame: Up to End of Study (approximately 145 weeks)
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 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Trial Transparency email recommended (Toll free for US & Canada) contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duvakitug in people with Hidradenitis, run by Sanofi.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) (time frame: At Week 16). 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 14 Oct 2026.