NCT01405196 (BUTTERFLY) is a Phase 2 clinical trial of PF-04236921 in Lupus Erythematosus, Systemic, sponsored by Pfizer.

Who is sponsoring NCT01405196?

NCT01405196 is sponsored by Pfizer.

What drugs are being tested in NCT01405196?

Interventions in NCT01405196: PF-04236921, PF-04236921, PF-04236921, PF-04236921.

What condition does NCT01405196 study?

NCT01405196 studies Lupus Erythematosus, Systemic.

Is NCT01405196 still recruiting?

NCT01405196 is currently completed. Last updated 18 December 2017.

Are results published for NCT01405196?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-12-18 · How we verify

NCT01405196: BUTTERFLY

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)

Completed Phase 2 Results posted Last updated 18 December 2017

What this trial tests

Phase 2 trial testing PF-04236921 in Lupus Erythematosus, Systemic in 183 participants. Completed in 1 March 2014.

Timeline

1 December 2011

Primary endpoint
1 March 2014

1 March 2014

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	183
Start date	1 December 2011
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	113 locations across United States, Argentina, Chile, Colombia, Germany, Hungary, Moldova, Peru

Drugs / interventions tested

PF-04236921 — full drug profile →
PF-04236921 — full drug profile →
PF-04236921 — full drug profile →
PF-04236921 — full drug profile →

Conditions studied

Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 75, any sex, with Lupus Erythematosus, Systemic. 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.

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
Time frame: Week 24
SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(\>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain sc

Sponsor's own description

The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.

Publications & conference data

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

Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).
Danese S, Vermeire S, Hellstern P, Panaccione R, et al · · 2019 · cited 137× · PMID 29247068 · DOI 10.1136/gutjnl-2017-314562
The discovery and development of belimumab: the anti-BLyS-lupus connection.
Stohl W, Hilbert DM. · · 2012 · cited 117× · PMID 22231104 · DOI 10.1038/nbt.2076
Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial.
Wallace DJ, Strand V, Merrill JT, Popa S, et al · · 2017 · cited 90× · PMID 27672124 · DOI 10.1136/annrheumdis-2016-209668
Systemic lupus erythematosus: updated insights on the pathogenesis, diagnosis, prevention and therapeutics.
Dai X, Fan Y, Zhao X. · · 2025 · cited 78× · PMID 40097390 · DOI 10.1038/s41392-025-02168-0
Cytokines as Biomarkers in Systemic Lupus Erythematosus: Value for Diagnosis and Drug Therapy.
Idborg H, Oke V. · · 2021 · cited 40× · PMID 34768756 · DOI 10.3390/ijms222111327
Cell type-specific mechanistic target of rapamycin-dependent distortion of autophagy pathways in lupus nephritis.
Caza T, Wijewardena C, Al-Rabadi L, Perl A. · · 2022 · cited 30× · PMID 35288362 · DOI 10.1016/j.trsl.2022.03.004
Analysis of transcriptomic features reveals molecular endotypes of SLE with clinical implications.
Hubbard EL, Bachali P, Kingsmore KM, He Y, et al · · 2023 · cited 16× · PMID 37845772 · DOI 10.1186/s13073-023-01237-9
An update on clinical trials for cutaneous lupus erythematosus.
Xie L, Lopes Almeida Gomes L, Stone CJ, Faden DF, et al · · 2024 · cited 13× · PMID 38491743 · DOI 10.1111/1346-8138.17161

Verify or expand the search:

Other recruiting trials for Lupus Erythematosus, Systemic

Currently open trials in the same condition.

NCT07424261 — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care · recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting
NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus · Phase 1 · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01405196 (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 Pfizer
Last refreshed: 18 December 2017

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/NCT01405196.

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