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NCT03502694: STEP
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus
Phase 2 trial testing Lumicitabine in Metapneumovirus. Withdrawn.
30 April 2019
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 5 November 2018 |
| Primary completion | 30 April 2019 |
| Estimated completion | 28 October 2020 |
| Sites | 112 locations across France, Japan, Netherlands, Russia, Malaysia, Ukraine, Sweden, Taiwan |
Drugs / interventions tested
- Lumicitabine — full drug profile →
- Placebo
Conditions studied
- Metapneumovirus — all drugs for Metapneumovirus →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
18 and older, any sex, with Metapneumovirus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine in hospitalized adult participants infected with human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV) and has been identified as an important cause of acute respiratory infections, affecting all age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Respiratory Viral Infections in Patients With Cancer or Undergoing Hematopoietic Cell Transplant.
Hijano DR, Maron G, Hayden RT. · · 2018 · cited 69× · PMID 30619176 · DOI 10.3389/fmicb.2018.03097 -
Are Community Acquired Respiratory Viral Infections an Underestimated Burden in Hematology Patients?
Popescu CM, Ursache AL, Feketea G, Bocsan C, et al · · 2019 · cited 9× · PMID 31684063 · DOI 10.3390/microorganisms7110521
Verify or expand the search:
- PubMed search for NCT03502694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lumicitabine
Trials testing the same drug.
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- NCT03441529 — A Crossover Study to Assess the Effect of Intravenous Infusion of Piperacillin/Tazobactam on the Pharmacokinetics of Ora · Phase 1 · completed
- NCT03332459 — A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants · Phase 2 · completed
- NCT03333317 — A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Admi · Phase 2 · terminated
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · 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 NCT03502694 (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 Janssen Research & Development, LLC
- Last refreshed: 15 November 2018
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/NCT03502694.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing