Last reviewed · How we verify
NCT06956196
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Stapokibatrt in Children With Moderate-to-severe Atopic Dermatitis
Phase 3 trial testing Stapokibatrt in Atopic Dermatitis in 240 participants. Not yet recruiting.
1 May 2026
Quick facts
| Lead sponsor | Keymed Biosciences Co.Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 May 2025 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Stapokibatrt — full drug profile →
- Placebo
Conditions studied
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
Sponsor
Keymed Biosciences Co.Ltd — full company profile →
Who can join
Adults 2 to 11, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18
Time frame: Up to week 18
The EASI is a composite index with scores ranging from 0 to 72. Four Atopic Dermatitis(AD) disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).
Sponsor's own description
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06956196
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
- NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
- NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
- NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
- NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
- NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting
Other Keymed Biosciences Co.Ltd trials
Trials by the same sponsor.
- NCT07519577 — A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-2） · Phase 2 · not yet recruiting
- NCT07166211 — Study of CM512 Injection in Subjects With Chronic Spontaneous Urticaria(CSU) · Phase 2 · recruiting
- NCT07175493 — A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia · Phase 1, PHASE2 · recruiting
- NCT07011524 — Study of CM512 Injection in Subjects With Moderate-to-severe Asthma · Phase 2 · recruiting
- NCT07039578 — Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis · 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 NCT06956196 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Keymed Biosciences Co.Ltd
- Last refreshed: 30 April 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/NCT06956196.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing