NCT01291810 is a Phase 2 clinical trial of TNF Kinoid in Crohn's Disease, sponsored by Neovacs.

Who is sponsoring NCT01291810?

NCT01291810 is sponsored by Neovacs.

What drugs are being tested in NCT01291810?

Interventions in NCT01291810: TNF Kinoid, WFI.

What condition does NCT01291810 study?

NCT01291810 studies Crohn's Disease.

Is NCT01291810 still recruiting?

NCT01291810 is currently completed. Last updated 17 September 2014.

Last reviewed 2014-09-17 · How we verify

NCT01291810

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

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease

Completed Phase 2 Last updated 17 September 2014

What this trial tests

Phase 2 trial testing TNF Kinoid in Crohn's Disease in 66 participants. Completed in 1 May 2014.

Timeline

1 February 2011

Primary endpoint
1 October 2012

1 May 2014

Quick facts

Lead sponsor	Neovacs
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	66
Start date	1 February 2011
Primary completion	1 October 2012
Estimated completion	1 May 2014
Sites	58 locations across Belgium, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Netherlands

Drugs / interventions tested

TNF Kinoid — full drug profile →
WFI — full drug profile →

Conditions studied

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

Sponsor

Neovacs — full company profile →

Who can join

Adults 18 to 65, 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.

Clinical remission, defined as a CDAI score ≤ 150 points at week 8.
Time frame: Week 8

Sponsor's own description

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising. The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Targeting IL-6 by both passive or active immunization strategies prevents bleomycin-induced skin fibrosis.
Desallais L, Avouac J, Fréchet M, Elhai M, et al · · 2014 · cited 60× · PMID 25059342 · DOI 10.1186/ar4672

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 Neovacs trials

Trials by the same sponsor.

NCT02980198 — Study of IFN-K in Dermatomyositis · Phase 2 · withdrawn
NCT02665364 — Phase IIb Study of IFN-K in Systemic Lupus Erythematosus · Phase 2 · terminated

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 NCT01291810 (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 Neovacs
Last refreshed: 17 September 2014

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/NCT01291810.

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