NCT03681067 (CDAID) is a Phase 1, PHASE2 clinical trial of GSK1070806 in Crohn Disease, sponsored by University of Birmingham.

Who is sponsoring NCT03681067?

NCT03681067 is sponsored by University of Birmingham.

What drugs are being tested in NCT03681067?

Interventions in NCT03681067: GSK1070806, Placebo- sodium chloride.

What condition does NCT03681067 study?

NCT03681067 studies Crohn Disease.

Is NCT03681067 still recruiting?

NCT03681067 is currently completed. Last updated 28 April 2021.

Last reviewed 2021-04-28 · How we verify

NCT03681067: CDAID

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

A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease

Completed Phase 1, PHASE2 Last updated 28 April 2021

What this trial tests

Phase 1, PHASE2 trial testing GSK1070806 in Crohn Disease in 5 participants. Completed in 2 June 2020.

Timeline

20 February 2019

Primary endpoint
2 June 2020

2 June 2020

Quick facts

Lead sponsor	University of Birmingham
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	5
Start date	20 February 2019
Primary completion	2 June 2020
Estimated completion	2 June 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

GSK1070806 — full drug profile →
Placebo- sodium chloride

Conditions studied

Crohn Disease — all drugs for Crohn Disease →

Sponsor

University of Birmingham

Who can join

16 and older, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial aims to investigate the safety, tolerability and clinical activity of humanised antibody GSK1070806 delivered via intravenous infusion in the treatment of patients with moderate-to-severe Crohn's disease. 30-36 patients will be enrolled into the trial, with two thirds of the patients receiving active drug and one third receiving placebo. After 30 patients have been recruited into the study the sample size will be reassessed and up to an additional 6 patients could be recruited (i.e. up to 36 patients).

Publications & conference data

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

Therapeutic modulation of inflammasome pathways.
Chauhan D, Vande Walle L, Lamkanfi M. · · 2020 · cited 163× · PMID 32770571 · DOI 10.1111/imr.12908
Type 2 Inflammation in Eosinophilic Esophagitis: From Pathophysiology to Therapeutic Targets.
Racca F, Pellegatta G, Cataldo G, Vespa E, et al · · 2021 · cited 50× · PMID 35095572 · DOI 10.3389/fphys.2021.815842
Mitochondria and sensory processing in inflammatory and neuropathic pain.
Silva Santos Ribeiro P, Willemen HLDM, Eijkelkamp N. · · 2022 · cited 41× · PMID 36324872 · DOI 10.3389/fpain.2022.1013577
Inflammasome and Its Therapeutic Targeting in Rheumatoid Arthritis.
Jiang Q, Wang X, Huang E, Wang Q, et al · · 2021 · cited 33× · PMID 35095918 · DOI 10.3389/fimmu.2021.816839
Interleukin-18 Binding Protein in Immune Regulation and Autoimmune Diseases.
Park SY, Hisham Y, Shin HM, Yeom SC, et al · · 2022 · cited 19× · PMID 35885055 · DOI 10.3390/biomedicines10071750
The 'speck'-tacular oversight of the NLRP3-pyroptosis pathway on gastrointestinal inflammatory diseases and tumorigenesis.
Arrè V, Scialpi R, Centonze M, Giannelli G, et al · · 2023 · cited 16× · PMID 37891577 · DOI 10.1186/s12929-023-00983-7
Intestinal Organoids as a Novel Complementary Model to Dissect Inflammatory Bowel Disease.
Schulte L, Hohwieler M, Müller M, Klaus J. · · 2019 · cited 10× · PMID 31015842 · DOI 10.1155/2019/8010645
Evaluation of causal associations between interleukin-18 levels and immune-mediated inflammatory diseases: a Mendelian randomization study.
Wu J, Zhang X, Wu D, Jin O, et al · · 2023 · cited 7× · PMID 38031150 · DOI 10.1186/s12920-023-01744-z

Verify or expand the search:

Other trials of GSK1070806

Trials testing the same drug.

NCT06447506 — Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis. · Phase 2 · terminated
NCT05999799 — A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Se · Phase 2 · terminated
NCT05590338 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1070806 After a Single Intr · Phase 1 · completed
NCT04975438 — Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis · Phase 1 · completed
NCT03522662 — Anti IL-18 (GSK1070806) in Behcet's Disease · Phase 2 · unknown

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

NCT06953791 — Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Pat · Phase 2 · recruiting
NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting

Other University of Birmingham trials

Trials by the same sponsor.

NCT07160686 — Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment · Phase 3 · not yet recruiting
NCT07446166 — TETANUS Antibody Detection in Saliva Study · NA · not yet recruiting
NCT07294794 — Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension · NA · not yet recruiting
NCT07246356 — Feasibility and Efficacy of GTEP for Birth Trauma · NA · recruiting
NCT06932653 — Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial · NA · 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 NCT03681067 (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 University of Birmingham
Last refreshed: 28 April 2021

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/NCT03681067.

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