NCT00541749 is a Phase 1 clinical trial of rhuMAb IFNalpha in Systemic Lupus Erythematosus, sponsored by Genentech, Inc..

Who is sponsoring NCT00541749?

NCT00541749 is sponsored by Genentech, Inc..

What drugs are being tested in NCT00541749?

Interventions in NCT00541749: rhuMAb IFNalpha.

What condition does NCT00541749 study?

NCT00541749 studies Systemic Lupus Erythematosus.

Is NCT00541749 still recruiting?

NCT00541749 is currently completed. Last updated 21 September 2011.

Last reviewed 2011-09-21 · How we verify

NCT00541749

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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

Completed Phase 1 Last updated 21 September 2011

What this trial tests

Phase 1 trial testing rhuMAb IFNalpha in Systemic Lupus Erythematosus in 60 participants. Completed.

Timeline

1 February 2007

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	1 February 2007

Drugs / interventions tested

rhuMAb IFNalpha — full drug profile →

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Systemic Lupus Erythematosus. 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.

The incidence and nature of laboratory abnormalities
Time frame: Length of study
The incidence, nature, and severity of adverse events
Time frame: Length of study

Sponsor's own description

This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.

Publications & conference data

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

Systemic lupus erythematosus biomarkers: the challenging quest.
Arriens C, Wren JD, Munroe ME, Mohan C. · · 2017 · cited 52× · PMID 28013203 · DOI 10.1093/rheumatology/kew407
Systemic Sclerosis Pathogenesis and Emerging Therapies, beyond the Fibroblast.
Sierra-Sepúlveda A, Esquinca-González A, Benavides-Suárez SA, Sordo-Lima DE, et al · · 2019 · cited 48× · PMID 30809542 · DOI 10.1155/2019/4569826
Anticytokine therapies in systemic lupus erythematosus.
La Cava A. · · 2010 · cited 24× · PMID 20636010 · DOI 10.2217/imt.10.29
Type I interferon antagonists in clinical development for lupus.
Paredes JL, Niewold TB. · · 2020 · cited 16× · PMID 32700979 · DOI 10.1080/13543784.2020.1797677
Unmet medical needs in lupus nephritis: solutions through evidence-based, personalized medicine.
Anders HJ, Weidenbusch M, Rovin B. · · 2015 · cited 6× · PMID 26413272 · DOI 10.1093/ckj/sfv072

Verify or expand the search:

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · 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
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other Genentech, Inc. trials

Trials by the same sponsor.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas · Phase 2 · recruiting
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00541749 (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 Genentech, Inc.
Last refreshed: 21 September 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/NCT00541749.

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