Clinical trials

Crohn’s Disease, Colitis Ulcerosa and Coeliakie

Sponsor and investigator initiated studies available for patients with Crohn’s disease Colitis Ulcerosa or Coeliakie

Research

Crohn’s Disease

The IBD clinical trial unit currently has several sponsor and investigator initiated studies available for patients with Crohn’s disease. The following studies are open for recruitment and all admissions go via ibdstudies@amsterdamumc.nl (+31 20 566 6545) or via specialist referral.

Sponsor: AbbVie Inc.
Protocol: M20-259 ‘SEQUENCE’
Investigational product: risankizumab (IL23p19 antibody)

Sponsor: Celgene (BMS)
Protocol: RPC01-3202 ‘YELLOWSTONE’
Investigational product: ozanimod (S1P receptor modulator)

Sponsor: Janssen Research & Development
Protocol: CNTO1959CRD3001 ‘GALAXI 3’
Investigational product: guselkumab (IL23p19 antibody)

Investigator: Prof. dr. G.R.A.M. D’Haens
Protocol: LOVE-CD
Investigational product: vedolizumab

Sponsor: Arena Pharmaceuticals, Inc.
Protocol: APD334-202EU ‘CULTIVATE’
Investigational product: etrazimod (S1P receptor modulator)

Sponsor: Bristol-Myers Squibb Research and Development
Protocol: IM011023
Investigational product: BMS-986165 (deucravacitinib, TYK2 inhibitor)

Sponsor: Boehringer Ingelheim
Protocol: 1368-0008
Investigational product: spesolimab (IL36 antibody)

Investigator: Prof. dr. G.R.A.M. D’Haens
Protocol: REPREVIO
Investigational product: vedolizumab

Investigator: Prof. dr. W.A. Bemelman and Dr. C.J. Buskens
Protocol: SPICY Trial
Surgery: patients will be randomised to mesenteric sparing ileocolic resection or to central mesenterectomy ileocolic resection.

Investigator: Dr. M. Löwenberg
Procotol: I-CARE
European prospective longitudinal observational multicenter cohort study to assess presence and extent of safety concerns for anti-TNF alone or In combination with thiopurines among IBD patients

Investigator: Prof. dr. W.A. Bemelman, Dr. C.J. Buskens, Prof. dr. C.IJ. Ponsioen and Prof. dr. G.R.A.M. D’Haens.
Protocol: PISA II-trial
Surgery: treatment of perianal fistulas in Crohn’s disease: surgical closure vs anti-TNF.
Document: Onderzoeksprotocol PISA-II study

Colitis Ulcerosa

The IBD clinical trial unit currently has several sponsor and investigator initiated studies available for patients with Crohn’s disease. The following studies are open for recruitment and all admissions go via ibdstudies@amsterdamumc.nl (+31 20 566 6545) or via specialist referral.

Sponsor: Bristol-Myers Squibb Research and Development
Protocol: IM011027
Investigational product: BMS-986165 (deucravacitinib, TYK2 inhibitor)

Sponsor: AbbVie Inc.
Protocol: M16-067 ‘INSPIRE’
Investigational product: risankizumab (IL23p19 antibody)

Sponsor: Alimentiv
Protocol: RP1706 ‘VERDICT’
Investigational product: vedolizumab

Investigator: Prof. dr. G.R.A.M. D’Haens
Protocol: RP1907 ‘PROPHETIC’
Investigational product: tofacitinib

Investigator: Prof. dr. C. Ponsioen
Protocol: TURN2
Investigational product: feces transplant

Investigator: Prof. dr. G.R.A.M. D’Haens
Protocol: RP1907 ‘PROPHETIC’
Investigational product: tofacitinib

Investigator: Dr. M. Löwenberg
Protocol: OPTIC
Investigational product: mercaptopurine

Investigator: Dr. C.J. Buskens, prof. dr. W.A. Bemelman, prof. dr. G.R.A.M. D’Haens
Protocol: ACCURE
Surgery: patients will be randomized to laparoscopic appendectomy or to no appendectomy in day care setting.

Investigator: Dr. C.J. Buskens, prof. dr. W.A. Bemelman, prof. dr. G.R.A.M. D’Haens
Protocol: COSTA
Surgery: observational cohort study to evaluate the effect of appendectomy surgery for therapy-refractory ulcerative colitis patients including therapy with biologicals.

Sponsor: Takeda
Protocol: Vedolizumab-4004 ‘EARNEST’
Investigational product: vedolizumab

Coeliakie

Sponsor: Provention Bio, Inc.
Protocol: PRV-015-002b ‘PROACTIVE’
Investigational product: mAb IL-15

Sponsor: Calypso Biotech BV
Protocol: CALY-CL19-001 ‘CALYPSO’
Investigational product: mAb IL-15