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- ||||| lunsekimig (SAR443765) / Sanofi
New P2 trial: Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (clinicaltrials.gov) - Nov 6, 2024
P2, N=1000, Recruiting, Sponsor: Sanofi
- |||| lunsekimig (SAR443765) / Sanofi
Enrollment open: AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma. (clinicaltrials.gov) - Oct 9, 2024
P2, N=467, Recruiting, Sponsor: Sanofi
Not yet recruiting --> Recruiting
- ||||| lunsekimig (SAR443765) / Sanofi
New P2 trial: AIRPHRODITE: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma. (clinicaltrials.gov) - Sep 23, 2024
P2, N=467, Not yet recruiting, Sponsor: Sanofi
- ||| lunsekimig (SAR443765) / Sanofi
Enrollment open: A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - Sep 19, 2024
P2, N=80, Recruiting, Sponsor: Sanofi
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || lunsekimig (SAR443765) / Sanofi
Trial completion date, Trial primary completion date: A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - Aug 26, 2024
P2, N=80, Not yet recruiting, Sponsor: Sanofi
Not yet recruiting --> Recruiting Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
- | lunsekimig (SAR443765) / Sanofi
Trial completion date: A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - Aug 23, 2024
P2, N=80, Not yet recruiting, Sponsor: Sanofi
Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Jan 2026 --> Jan 2027 Trial completion date: Apr 2027 --> Apr 2026
- || lunsekimig (SAR443765) / Sanofi
Clinical, P1 data, Journal: A first-in-human, single and multiple dose study of lunsekimig, a novel anti-TSLP/anti-IL-13 NANOBODY (Pubmed Central) - Jun 26, 2024
ADA of low titers were detected in four (11.1%) participants who received lunsekimig in the SAD, and seven (43.8%) in the MAD. In conclusion, lunsekimig was well tolerated in healthy participants with a linear PK profile up to single 400?mg IV and SC dose and multiple doses of 100 and 200?mg SC Q2W, with low immunogenicity.
- |||| lunsekimig (SAR443765) / Sanofi
New P2 trial: A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - Jun 11, 2024
P2, N=80, Not yet recruiting, Sponsor: Sanofi
- lunsekimig (SAR443765) / Sanofi
TSLP AND IL-13 Dual Blockade By Lunsekimig Provides Broader Benefits On Type-2 Inflammation (PS-14; Poster board no. 20) - May 31, 2024 - Abstract #ERS2024ERS_4807;
Indeed, lunsekimig was more potent in inhibiting TARC and eotaxin-3 production than targeting TSLP (tezepelumab) or IL-13 (lebrikizumab) alone in an allergen-stimulated triculture assay. Lunsekimig had significantly lowered plasma human IL
- lunsekimig (SAR443765) / Sanofi
Single-cell RNA Sequencing Analysis of Blood and Nasal Brushing From Asthma Patients Receiving a Single Dose of SAR443765, A Novel, Bispecific Anti-TSLP/Anti-IL-13 Nanobody (Marriott Marquis San Diego Marina, Pacific Ballroom 24-26 (Ground Floor, North Tower)) - Feb 20, 2024 - Abstract #ATS2024ATS_2952;
P1
1NANOBODY is a registered trademark by Sanofi. 2Deiteren et al.
- || Review, Journal, Stroma: Investigational thymic stromal lymphopoietin inhibitors for the treatment of asthma: a systematic review. (Pubmed Central) - Jan 11, 2024
anti-TSLP monoclonal antibody (mAb) tezepelumab...Ecleralimab, an inhaled antibody fragment antigen binding, shows promising evidence in enhancing efficacy and reducing systemic adverse events. SAR443765, with its NANOBODY
- ||||| lunsekimig (SAR443765) / Sanofi
New P2 trial: AIRCULES: Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma (clinicaltrials.gov) - Oct 25, 2023
P2, N=630, Recruiting, Sponsor: Sanofi
- SAR443765 / Sanofi
Late Breaking Abstract - Early improvement in asthma small airway dysfunction after one dose of SAR443765, a novel bispecific anti-thymic stromal lymphopoietin/anti-IL-13 nanobody molecule (Red 1+2) - Jul 4, 2023 - Abstract #ERS2023ERS_5471;
SAR443765, with its NANOBODY Endoscopy and interventional pulmonology; Imaging; Pulmonary function testing; Pulmonary rehabilitation; Transplantation; General respiratory patient care; Physiology; Cell and molecular biology
- SAR443765 / Sanofi
Targeting of TSLP and IL-13 by the Novel NANOBODY (Walter E. Washington Convention Center, Ballroom C (Level 3)) - Apr 30, 2023 - Abstract #ATS2023ATS_9025;
P1
Notwithstanding that lung function was normal to near-normal at baseline, rapid numerical improvement was seen for pre-bronchodilator FEV1 in the SAR443765 group as of week 1 that was largely maintained through Day 29.This is the first report of a novel biological targeting both TSLP and IL-13. The rapid and substantial reduction seen in FeNO surpasses that seen in monovalent targeting of either pathway and suggests the potential for superior suppression of airway inflammation and preservation in airway function in asthma.This study was funded by Sanofi.
- || lunsekimig (SAR443765) / Sanofi
Trial completion: First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants (clinicaltrials.gov) - Apr 12, 2023
P1, N=36, Completed, Sponsor: Sanofi
The rapid and substantial reduction seen in FeNO surpasses that seen in monovalent targeting of either pathway and suggests the potential for superior suppression of airway inflammation and preservation in airway function in asthma.This study was funded by Sanofi. Active, not recruiting --> Completed
- || lunsekimig (SAR443765) / Sanofi
Enrollment closed: First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants (clinicaltrials.gov) - Jan 9, 2023
P1, N=36, Active, not recruiting, Sponsor: Sanofi
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | lunsekimig (SAR443765) / Sanofi
Trial completion date, Trial primary completion date: First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants (clinicaltrials.gov) - Oct 5, 2022
P1, N=36, Recruiting, Sponsor: Sanofi
Recruiting --> Active, not recruiting Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023
- || lunsekimig (SAR443765) / Sanofi
Enrollment change: First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants (clinicaltrials.gov) - Jun 23, 2022
P1, N=36, Recruiting, Sponsor: Sanofi
Trial completion date: Dec 2022 --> Apr 2023 | Trial primary completion date: Dec 2022 --> Apr 2023 N=72 --> 36
- ||| lunsekimig (SAR443765) / Sanofi
Enrollment open: First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants (clinicaltrials.gov) - May 18, 2022
P1, N=72, Recruiting, Sponsor: Sanofi
N=72 --> 36 Not yet recruiting --> Recruiting
- ||| lunsekimig (SAR443765) / Sanofi
New P1 trial: First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants (clinicaltrials.gov) - May 8, 2022
P1, N=72, Not yet recruiting, Sponsor: Sanofi