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NCT04038970
Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Phase 2 trial testing KN019, 5mg/kg in Rheumatoid Arthritis in 145 participants. Completed in 28 July 2022.
28 July 2022
Quick facts
| Lead sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 145 |
| Start date | 8 November 2019 |
| Primary completion | 28 July 2022 |
| Estimated completion | 28 July 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- KN019, 5mg/kg — full drug profile →
- KN019, 10 mg/kg — full drug profile →
- Placebo
- Methotrexate — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd — full company profile →
Who can join
18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of KN019 after intravenous administration on background methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting rheumatoid arthritis: a molecular perspective on biologic therapies and clinical progress.
Jain A, Bishnoi M, Prajapati SK, Acharya S, et al · · 2025 · cited 3× · PMID 40707975 · DOI 10.1186/s13036-025-00534-8
Verify or expand the search:
- PubMed search for NCT04038970
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
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- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials
Trials by the same sponsor.
- NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H · Phase 3 · recruiting
- NCT07391644 — A Study of JSKN027 in Patients With Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07475559 — JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors · Phase 1 · not yet recruiting
- NCT07283198 — A Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics/Pharmacodynamics of JSKN033 in Patients Wit · Phase 2 · not yet recruiting
- NCT07292402 — JSKN022 in Subjects With Advanced Malignant Solid Tumors · Phase 1 · 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 NCT04038970 (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 Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Last refreshed: 1 March 2023
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/NCT04038970.
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