Trial record 1 of 1 for:
ACT16852
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (HS OBTAIN)
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| ClinicalTrials.gov Identifier: NCT05849922 |
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Recruitment Status :
Recruiting
First Posted : May 9, 2023
Last Update Posted : October 30, 2023
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Brief Summary:
This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hidradenitis Suppurativa | Drug: SAR442970 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 114 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa |
| Actual Study Start Date : | June 6, 2023 |
| Estimated Primary Completion Date : | October 17, 2024 |
| Estimated Study Completion Date : | February 7, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
| Arm | Intervention/treatment |
|---|---|
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Experimental: SAR442970
Participants will receive SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).
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Drug: SAR442970
1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial |
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Placebo Comparator: Placebo
Participants will receive placebo Q2W in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Up to Week 28).
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Drug: Placebo
1 mL extractable volume of placebo filled in 2 mL glass vial |
Primary Outcome Measures :
- Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) [ Time Frame: Week 16 ]HiSCR50 is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
Secondary Outcome Measures :
- Time to onset of achieving HiSCR50 [ Time Frame: Up to week 16 ]
- Percentage of participants achieving HiSCR75 at Week 16 [ Time Frame: Week 16 ]HiSCR75 is defined as at least a 75% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
- Percentage of participants achieving HiSCR90 at week 16 [ Time Frame: Week 16 ]HiSCR90 is defined as at least a 90% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
- Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16 [ Time Frame: Week 16 ]The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient
- Change in absolute score from Baseline in IHS4 at week 16 [ Time Frame: From Baseline to week 16 ]
- Percentage of participants who experience a flare [ Time Frame: Week 16 ]Flare is defined as at least 25% increase in the total abscess and inflammatory nodule [AN] count (with a minimum increase of 2) relative to Baseline at week 16.
- Percentage of participants achieving IHS4-55 [ Time Frame: Week 16 ]IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from Baseline
- Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions [ Time Frame: Up to week 36 ]
- Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-SkinPainNRS) at Week 16 among participants with Baseline NRS ≥3 [ Time Frame: Week 16 ]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)
- Serum SAR442970 concentrations throughout the study [ Time Frame: Up to 36 weeks ]
- Incidence of anti-SAR442970 antibody positive response throughout the study [ Time Frame: Up to 36 weeks ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, demonstrated intolerance to antibiotics, or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
- Participants must be either biologic and small molecule immunosuppressive-naïve or TNF-experienced.
- Participant must have a total abscess and inflammatory nodule (AN) count of ≥3 at the Baseline visit.
- Participant must have a draining tunnel count of ≤20 at the Baseline visit.
- Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit.
- Participant who is a candidate for systemic treatment per Investigator's judgment.
Exclusion Criteria:
- Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that may interfere with assessment of HS
- History of recurrent or recent serious infection
- Known history of or suspected significant current immunosuppression
- History of solid organ transplant
- History of splenectomy
- History of moderate to severe congestive heart failure
- Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured
- Participants with a diagnosis of inflammatory conditions other than HS
- Presence of active suicidal ideation, or positive suicide behavior or participant has a lifetime history of suicide attempt, or participant has had suicidal ideation in the past 6 months as indicated by a positive response using the screening or Baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history
- A history of an adverse event (AE) to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Female participants who are breastfeeding or considering becoming pregnant during the study
- History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
- Laboratory exclusion criteria apply
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05849922
Contacts
| Contact: Trial transparency email recommended (Toll free for US & Canada | 800-633-1610 ext option 6 | contact-us@sanofi.com |
Locations
Show 19 study locations
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT05849922 |
| Other Study ID Numbers: |
ACT16852 U1111-1280-6493 ( Registry Identifier: ICTRP ) 2022-502370-17 ( Other Identifier: CTIS ) 2022-502370-17 ( EudraCT Number ) |
| First Posted: | May 9, 2023 Key Record Dates |
| Last Update Posted: | October 30, 2023 |
| Last Verified: | October 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |