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NCT05986162
Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis
Phase 1 trial testing Itolizumab in Dermatomyositis, Adult Type in 44 participants. Status unknown.
3 May 2025
Quick facts
| Lead sponsor | Biotech Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 30 December 2023 |
| Primary completion | 3 May 2025 |
| Estimated completion | 25 June 2025 |
Drugs / interventions tested
- Itolizumab — full drug profile →
Conditions studied
- Dermatomyositis, Adult Type — all drugs for Dermatomyositis, Adult Type →
Sponsor
Biotech Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Dermatomyositis, Adult Type. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of Itolizumab in subjects with Dermatomyositis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Dermatomyositis: Practical Guidance and Unmet Needs.
Cassard L, Seraly N, Riegert M, Patel A, et al · · 2024 · cited 14× · PMID 38464459 · DOI 10.2147/itt.s381472
Verify or expand the search:
- PubMed search for NCT05986162
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Itolizumab
Trials testing the same drug.
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- NCT05263999 — A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Diseas · Phase 3 · terminated
Other Biotech Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07582822 — JH021 in Patients With Advanced Solid Tumors or EGFR-Mutant NSCLC · Phase 1 · not yet recruiting
- NCT07510841 — JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR · Phase 1, PHASE2 · not yet recruiting
- NCT06633055 — A Phase I Clinical Trial of JH013 Injection · Phase 1 · not yet recruiting
- NCT05978050 — Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma · Phase 3 · recruiting
- NCT06333821 — A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma · Phase 3 · not yet 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 NCT05986162 (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 Biotech Pharmaceutical Co., Ltd.
- Last refreshed: 14 August 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/NCT05986162.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing