brivekimig (SAR442970) / Sanofi - LARVOL DELTA

Impact on quality of life and patient-reported outcomes of brivekimig for the treatment of particpants with moderate-to-severe hidradenitis suppurativa (EADV 2026) - No abstract available

Clinical • HEOR • Patient reported outcomes • Dermatology • Hidradenitis Suppurativa • Immunology

Brivekimig improves draining tunnel resolution and International Hidradenitis Suppurativa Severity Score System (IHS4) in moderate-to-severe hidradenitis suppurativa: Results from the HS OBTAIN trial (EADV 2026) - No abstract available

Dermatology • Hidradenitis Suppurativa • Immunology

BRIGHTEN: Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=208 | Recruiting | Sponsor: Sanofi | Trial completion date: Apr 2028 ➔ Nov 2029 | Trial primary completion date: Aug 2027 ➔ Feb 2027

Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

Brivekimig: Data from P2 trial (NCT07170917) for hidradenitis suppurativa in 2027 (Sanofi) - Q2 2026 Results

P2 data • Hidradenitis Suppurativa

CHROMA CD: A study to investigate efficacy and safety of brivekimig in participants with Crohns disease (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Sanofi

Trial initiation date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

COLOR UC: A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Sanofi

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DRI19220: Brivekimig for the treatment of moderate to severe hidradenitis suppurativa (clinicaltrialsregister.eu) - P1/2 | N=132 | Recruiting | Sponsor: Sanofi-Aventis Recherche & Developpement

New P1/2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

T1D OBTAIN: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2028 ➔ Apr 2027 | Trial primary completion date: Aug 2027 ➔ Apr 2027

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Brivekimig: Data from P2 trial (NCT07170917) for hidradenitis suppurativa in 2027 (Sanofi, 44th Annual J.P. Morgan Healthcare Conference)

P2 data • Hidradenitis Suppurativa

Brivekimig: Data from P2 trial (NCT07170917) for hidradenitis suppurativa in 2027 (Sanofi, 44th Annual J.P. Morgan Healthcare Conference)

P2 data • Hidradenitis Suppurativa

BRIGHTEN: Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=188 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

Brivekimig: “Achieved primary objective in HS phase 2 study”; Hidradenitis Suppurativa (Sanofi) - Q3 2025 Results

P2 data • Hidradenitis Suppurativa

Efficacy and safety of brivekimig (a dual-target, anti-tumour necrosis factor and anti-OX40 ligand NANOBODY®-based biologic) in participants with moderate-to-severe hidradenitis suppurativa (EADV 2025) - P2 | "Clinically meaningful improvements in HS were achieved with brivekimig 150 mg given subcutaneously Q2W in the biologic-naïve (primary analysis) population. No new safety concerns were identified that were incongruent with previously identified anti-TNF class therapies. Targeting of TNF and OX40L pathways may be a promising strategy to reduce inflammation, leading to improvement in HS."

Clinical • Dermatology • Hidradenitis Suppurativa • Immunology • Infectious Disease • Oncology • TNFSF4

Press Release: EADV: Sanofi’s brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study (GlobeNewswire) - "HiSCR50, defined as ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline, median response rates were 67% in the brivekimig arm (n=48) versus 37% (n=23) in the placebo arm (Bayesian primary analysis with estimated difference of 29%; 90% credible interval: 10%–47%; probability of superiority: 99.28%)."

P2a data • Hidradenitis Suppurativa

BRIGHTEN: Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=188 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

CHROMA CD: A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

COLOR UC: A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=99 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Combined TNF-α and OX40L targeting as a new treatment option for hidradenitis suppurativa. (PubMed, J Allergy Clin Immunol Glob) - "Increased numbers of cells expressing OX40 were observed in HS lesions, and bioinformatics analyses of single-cell and bulk RNA sequencing data identified cells expressing OX40 as T cells with a highly mobile phenotype. OX40-OX40L interaction is a key pathogenetic feature in HS, and patients with HS might benefit from combined TNF-α/OX40L blockade by SAR442970, which is currently investigated in a clinical phase 2 trial."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Hidradenitis Suppurativa • Immunology • Inflammation • TNFA • TNFSF4

Sanofi's Phase II study of TNF-α/OX40L dual antibody was successful [Google translation] (163.com) - P2 | N=86 | HS OBTAIN (NCT05849922) | Sponsor: Sanofi | "On April 24, Sanofi revealed when announcing its first-quarter results that the Phase II study of brivekimig (SAR442970) for the treatment of hidradenitis suppurativa (HS) reached the primary endpoint....The results showed that among patients with moderate to severe HS who had not received treatment with biologics, the proportion of patients who achieved HiSCR50 in the brivekimig (once every 2 weeks) group was clinically significant compared with the placebo group. In other indicators, the brivekimig group also achieved clinically significant improvements. In addition, during the 28-week treatment period, the safety of brivekimig was in line with expectations, and no new safety signals were found."

P2 data • Hidradenitis Suppurativa

CHROMA CD: A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease (clinicaltrials.gov) - P2 | N=99 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

COLOR UC: A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=99 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

T1D OBTAIN: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

T1D OBTAIN: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=86 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Hidradenitis Suppurativa • Immunology • CRP

RESULT: A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Sanofi | Initiation date: Aug 2024 ➔ Dec 2024

Trial initiation date • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Lupus Nephritis • Nephrology