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NCT06033833: RIVER-ASTHMA
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
Phase 2 trial testing Amlitelimab in Asthma in 335 participants. Participants enrolled and being followed up; not accepting new ones.
25 June 2029
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 335 |
| Start date | 5 September 2023 |
| Primary completion | 25 June 2029 |
| Estimated completion | 25 June 2029 |
| Sites | 68 locations across Italy, South Africa, Japan, Chile, United Kingdom, Hungary, Mexico, Poland |
Drugs / interventions tested
- Amlitelimab — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Sanofi — full company profile →
Who can join
Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Therapeutic monoclonal antibodies in allergy: Targeting IgE, cytokine, and alarmin pathways.
Eggel A, Pennington LF, Jardetzky TS. · · 2024 · cited 45× · PMID 39158477 · DOI 10.1111/imr.13380 -
Emerging Systemic Treatments for Asthma and Allergic Diseases: New Tricks, Same Dog?
Tomasello A, Szefler SJ, Cahill KN. · · 2026 · cited 2× · PMID 40912614 · DOI 10.1016/j.jaip.2025.08.022
Verify or expand the search:
- PubMed search for NCT06033833
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Amlitelimab
Trials testing the same drug.
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- NCT06557772 — A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease · Phase 2 · active not recruiting
- NCT06444451 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Parti · Phase 2 · active not recruiting
- NCT06407934 — A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Tre · Phase 3 · active not recruiting
- NCT06241118 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in · Phase 3 · recruiting
Other recruiting trials for Asthma
Currently open trials in the same condition.
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- NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
- NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
- NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06033833 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06033833.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing