NCT00396422 is a Phase 2 clinical trial of RWJ-445380 in Chronic Small Plaque Psoriasis, sponsored by Alza Corporation, DE, USA.

Who is sponsoring NCT00396422?

NCT00396422 is sponsored by Alza Corporation, DE, USA.

What drugs are being tested in NCT00396422?

Interventions in NCT00396422: RWJ-445380.

What condition does NCT00396422 study?

NCT00396422 studies Chronic Small Plaque Psoriasis.

Is NCT00396422 still recruiting?

NCT00396422 is currently completed. Last updated 17 February 2011.

Last reviewed 2011-02-17 · How we verify

NCT00396422

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase IIa Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multi-Center, Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RWJ-445380 Administered to Patients With Plaque Psoriasis

Completed Phase 2 Last updated 17 February 2011

What this trial tests

Phase 2 trial testing RWJ-445380 in Chronic Small Plaque Psoriasis in 60 participants. Completed in 1 March 2007.

Timeline

1 September 2006

1 March 2007

Quick facts

Lead sponsor	Alza Corporation, DE, USA
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 September 2006
Estimated completion	1 March 2007

Drugs / interventions tested

RWJ-445380 — full drug profile →

Conditions studied

Chronic Small Plaque Psoriasis — all drugs for Chronic Small Plaque Psoriasis →

Sponsor

Alza Corporation, DE, USA — full company profile →

Who can join

18 and older, any sex, with Chronic Small Plaque Psoriasis. 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.

Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory assessments, physical exam and ECGs in patients with psoriasis

Sponsor's own description

The primary objective of the study is to evaluate the safety and tolerability of 50, 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with plaque psoriasis

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Longitudinal analysis of tear cathepsin S activity levels in male non-obese diabetic mice suggests its potential as an early stage biomarker of Sjögren's Syndrome.
Janga SR, Shah M, Ju Y, Meng Z, et al · · 2019 · cited 17× · PMID 30126300 · DOI 10.1080/1354750x.2018.1514656
Cathepsin S: molecular mechanisms in inflammatory and immunological processes.
Gao H, Zhang Z, Deng J, Song Y. · · 2025 · cited 9× · PMID 40692794 · DOI 10.3389/fimmu.2025.1600206
PP2A: A Novel Target to Prevent Cathepsin S-mediated Damage in Smoking-induced Chronic Obstructive Pulmonary Disease.
Janga SR, Hamm-Alvarez SF. · · 2019 · cited 3× · PMID 30785780 · DOI 10.1164/rccm.201901-0219ed

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00396422 (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 Alza Corporation, DE, USA
Last refreshed: 17 February 2011

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/NCT00396422.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing