NCT01345318 (ANDANTE II) is a Phase 2 clinical trial of PF-04236921 in Crohn's Disease, sponsored by Pfizer.

Who is sponsoring NCT01345318?

NCT01345318 is sponsored by Pfizer.

What drugs are being tested in NCT01345318?

Interventions in NCT01345318: PF-04236921, PF-04236921.

What condition does NCT01345318 study?

NCT01345318 studies Crohn's Disease.

Is NCT01345318 still recruiting?

NCT01345318 is currently completed. Last updated 10 January 2024.

Are results published for NCT01345318?

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

Last reviewed 2024-01-10 · How we verify

NCT01345318: ANDANTE II

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

A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

Completed Phase 2 Results posted Last updated 10 January 2024

What this trial tests

Phase 2 trial testing PF-04236921 in Crohn's Disease in 191 participants. Completed in 1 March 2016.

Timeline

1 June 2011

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	191
Start date	1 June 2011
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	127 locations across United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France

Drugs / interventions tested

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

Conditions studied

Crohn's Disease — all drugs for Crohn's Disease →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 75, any sex, with Crohn's Disease. 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.

Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
Time frame: Baseline up to Week 48
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack
Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Time frame: At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.
Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (\>=) 4.32. Any positive ADA sample was further tested for NAbs.

Sponsor's own description

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

Publications & conference data

6 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
Role of interleukin-6-mediated inflammation in the pathogenesis of inflammatory bowel disease: focus on the available therapeutic approaches and gut microbiome.
Shahini A, Shahini A. · · 2023 · cited 105× · PMID 36112307 · DOI 10.1007/s12079-022-00695-x
The double-edged effects of IL-6 in liver regeneration, aging, inflammation, and diseases.
Wang MJ, Zhang HL, Chen F, Guo XJ, et al · · 2024 · cited 43× · PMID 38890694 · DOI 10.1186/s40164-024-00527-1
Dissecting Innate and Adaptive Immunity in Inflammatory Bowel Disease: Immune Compartmentalization, Microbiota Crosstalk, and Emerging Therapies.
Yue N, Hu P, Tian C, Kong C, et al · · 2024 · cited 9× · PMID 39634289 · DOI 10.2147/jir.s492079
Deciphering the immunocellular regulatory network in inflammatory bowel disease: from susceptibility genes to cellular effectors and toward precision therapies.
Wu Z, Wang X, Guan Z, Han M, et al · · 2025 · PMID 41675494 · DOI 10.3389/fimmu.2025.1719366
Differential Roles of Interleukin-6 in Severe Acute Respiratory Syndrome-Coronavirus-2 Infection and Cardiometabolic Diseases.
Ren J, Wang XQ, Nakao T, Libby P, et al · · 2023 · PMID 38152628 · DOI 10.1097/cd9.0000000000000096

Verify or expand the search:

Other recruiting trials for Crohn's Disease

Currently open trials in the same condition.

NCT07273188 — 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease · EARLY_PHASE1 · recruiting
NCT07184944 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184931 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · 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 NCT01345318 (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: 10 January 2024

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/NCT01345318.

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