NCT01287897: ANDANTE

A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)

Completed Phase 2 Results posted Last updated 14 December 2015

What this trial tests

Phase 2 trial testing PF-04236921 SC injection in Crohn's Disease in 250 participants. Completed in 1 February 2015.

Timeline

1 February 2011

Primary endpoint
1 September 2014

1 February 2015

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	1 February 2011
Primary completion	1 September 2014
Estimated completion	1 February 2015
Sites	193 locations across United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France

Drugs / interventions tested

• PF-04236921 SC injection — full drug profile →
• PF-04236921 SC injection — full drug profile →
• PF-04236921 SC injection — 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.

• The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
  Time frame: Baseline and Week 8
  CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score gre
• The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
  Time frame: Baseline and Week 8
  CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 and
• The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
  Time frame: Baseline and Week 12
  CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite scor
• The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
  Time frame: Baseline and Week 12
  CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score \>=0 an

Sponsor's own description

This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

Publications & conference data

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

1. Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics.
   Lu Q, Yang MF, Liang YJ, Xu J, et al · · 2022 · cited 139× · PMID 35310454 · DOI 10.2147/jir.s353038
2. 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
3. Potential therapeutic implications of IL-6/IL-6R/gp130-targeting agents in breast cancer.
   Heo TH, Wahler J, Suh N. · · 2016 · cited 95× · PMID 26840088 · DOI 10.18632/oncotarget.7102
4. Context-Dependent Regulation of Type17 Immunity by Microbiota at the Intestinal Barrier.
   Akuzum B, Lee JY. · · 2022 · cited 20× · PMID 36627936 · DOI 10.4110/in.2022.22.e46
5. 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
6. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease.
   Li C, Shoji S, Beebe J. · · 2018 · cited 9× · PMID 29776017 · DOI 10.1111/bcp.13641
7. 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
8. 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