A study to test the efficacy and safety of SAR442970 in adults with hidradenitis suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

14 Nov 2023 → 10 Jan 2025

Decision date (initial)

2023-08-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Research & Development

External identifiers

EU CT number

2022-502370-17-00

WHO UTN

U1111-1280-6493

ClinicalTrials.gov

NCT05849922

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

To evaluate the efficacy of SAR442970 during the double blind, placebo-controlled period in the biologic and small molecule immunosuppressive-naïve subgroup of participants with hidradenitis suppurativa (HS)

Secondary objectives 3

1. To evaluate the efficacy and safety of SAR442970 in the biologic and small molecule immunosuppressive-naïve subgroup and TNF-experienced subgroup of participants with HS
2. To evaluate the effect of SAR442970 on pain in participants with HS
3. To evaluate the pharmacokinetics (PK) of SAR442970 and anti-drug antibodies to SAR442970 in the biologic and small molecule immunosuppressive-naïve subgroup and TNF-experienced subgroup of participants with HS

Conditions and MedDRA coding

Hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year prior to baseline.
2. 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
3. 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
4. Participants must be either biologic and small molecule immunosuppressive-naïve or TNF-experienced
5. Participant must have a total abscess and inflammatory nodule (AN) count of ≥3 at the baseline visit
6. Participant must have a draining tunnel count of ≤20 at the baseline visit
7. Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit
8. Participant who is a candidate for systemic treatment per Investigator’s judgment

Exclusion criteria 16

1. Any other active skin disease or condition (eg, bacterial, fungal or viral infection) that may interfere with assessment of HS
2. Participants with a diagnosis of inflammatory conditions other than HS
3. 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
4. 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 re administration of an anti-TNF class therapy
5. 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
6. Female participants who are breastfeeding or considering becoming pregnant during the study
7. History (within last 2 years prior to baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator
8. History of recurrent or recent serious infection
9. Known history of or suspected significant current immunosuppression
10. History of solid organ transplant
11. History of splenectomy
12. History of moderate to severe congestive heart failure
13. Receipt of a live vaccine 12 week prior to baseline visit or receipt of a killed vaccine 2 weeks prior to baseline visit
14. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
15. 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
16. Laboratory exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of biologic and small molecule immunosuppressive naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)

Secondary endpoints 11

1. Time to onset of achieving HiSCR50
2. Percentage of participants achieving HiSCR75 at Week 16
3. Percentage of participants achieving HiSCR90 at week 16
4. Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16
5. Change in absolute score from baseline in IHS4 at week 16
6. Percentage of participants who experience a flare
7. Percentage of participants achieving IHS4-55
8. Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions
9. 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-Skin Pain NRS) at Week 16 among participants with baseline NRS ≥3
10. Serum SAR442970 concentrations throughout the study
11. Incidence of anti-SAR442970 antibody positive response throughout the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Research & Development

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Research & Development

Contact name

Clinical Sciences and Operations

Third parties 6

Locations

11 EU/EEA countries · 37 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 51 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

14 submissions — initial application plus substantial / non-substantial modifications