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10 Diseases |  |
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56 News |  |
- || Review, Journal: Old and New Biologics and Small Molecules in Inflammatory Bowel Disease: Anti Integrins (Pubmed Central) - Aug 23, 2024
In addition, the introduction of subcutaneous vedolizumab showed similar efficacy and safety with improved patients' convenience. Other investigational anti-integrin therapies include abrilumab (anti-?4?7 IgG2), PN-943 (orally administered and gut-restricted ?4?7 antagonist peptide), AJM300 (orally active small molecule inhibitor of ?4), and ontamalimab (anti-MAdCAM-1 IgG).
- || Clinical, Journal: Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): Insights into promising agents. (Pubmed Central) - Nov 12, 2021
Among the most exciting features of this class are the gut selectivity, the convenient subcutaneous and oral administrations and the reassuring safety profiles. Most of the new anti-integrins seem to improve outcomes in UC but not in CD, however these data are far from definitive and several pivotal trials are still under way.
- || Entyvio (vedolizumab) / Takeda
Review, Journal: Anti-Integrins for the Treatment of Inflammatory Bowel Disease: Current Evidence and Perspectives. (Pubmed Central) - Sep 2, 2021
Vedolizumab (anti-α4β7) is approved for the treatment of ulcerative colitis (UC) and CD...Large phase 3 clinical trials evaluating efficacy of etrolizumab in the induction and maintenance of patients with IBD are underway. Other investigational anti-integrin therapies include abrilumab (anti-α4β7 IgG2), PN-943 (orally administered and gut-restricted α4β7 antagonist peptide), AJM300 (orally active small molecule inhibitor of α4), and ontamalimab (anti-MAdCAM-1 IgG).
- || Entyvio (vedolizumab) / Takeda
Review, Journal: Emerging Treatment Options in Inflammatory Bowel Disease: Janus Kinases, Stem Cells, and More. (Pubmed Central) - Aug 20, 2021
Key messages: New IBD treatments are successful for a significant fraction of patients. However, new strategies for patient selection, treatment combinations, and/or additional therapies must be developed to serve the need of all IBD patients.
- ||||| abrilumab (AMG 181) / Amgen
P2b data: 7/13 Another new & upcoming anti-integrin: 🔑#abrilumab ✅anti-α4β7 🔺SQ 🔺Ph2b RCT in mod–sev active UC w/ inadequate response to conventional therapies 👇👇 @AGA_Gastro (Twitter) - Nov 9, 2020
- | Entyvio (vedolizumab) / Takeda
Review, Journal: Interfering with leukocyte trafficking in Crohn's disease. (Pubmed Central) - Nov 14, 2019
Oral and subcutaneous therapies are in development. The safety, efficacy and practice points of licensed drugs are discussed, in addition to initial results from therapeutic trials.
- | Stelara (ustekinumab) / J&J, Xeljanz (tofacitinib) / Pfizer, Entyvio (vedolizumab) / Takeda
Review, Journal: Emerging Therapies for Inflammatory Bowel Disease. (Pubmed Central) - Sep 28, 2019
Other agents are currently being developed at various stages of clinical trials including anti-adhesion agents such as etrolizumab and abrilumab, JAK inhibitors such as tofacitinib, and anti-trafficking molecules...It is projected that many therapies will become available in the coming years if supported by the results of current clinical trials. This will provide IBD patients with a wide array of options and allow physicians to choose the best therapies for each individual patient.
- | abrilumab (AMG 181) / Amgen
Biomarker, Clinical, Journal: Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate to Severe Ulcerative Colitis. (Pubmed Central) - Apr 5, 2019
P2
This will provide IBD patients with a wide array of options and allow physicians to choose the best therapies for each individual patient. Abrilumab treatment for 8 weeks induced remission, clinical response, and mucosal healing in patients with moderate-to-severe UC.
- || abrilumab (AMG 181) / Amgen, AstraZeneca
Trial completion: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - Jun 1, 2018
P2, N=44, Completed, Sponsor: AstraZeneca
Abrilumab treatment for 8 weeks induced remission, clinical response, and mucosal healing in patients with moderate-to-severe UC. Active, not recruiting --> Completed
- |||| abrilumab (AMG 181) / Amgen, AstraZeneca
Trial completion: Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - Apr 19, 2018
P2, N=254, Completed, Sponsor: Amgen
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| abrilumab (AMG 181) / Amgen, AstraZeneca
Trial completion: Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Apr 18, 2018
P2, N=359, Completed, Sponsor: Amgen
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment change: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - May 23, 2017
P2, N=44, Active, not recruiting, Sponsor: AstraZeneca
Active, not recruiting --> Completed N=59 --> 44
- || abrilumab (AMG 181) / Amgen, AstraZeneca
Trial primary completion date: Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Mar 7, 2016
P2, N=359, Active, not recruiting, Sponsor: Amgen
N=59 --> 44 Trial primary completion date: Oct 2017 --> Jul 2015
- ||| abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment change: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - Jan 7, 2016
P2, N=59, Active, not recruiting, Sponsor: AstraZeneca
Trial primary completion date: Oct 2017 --> Jul 2015 N=48 --> 59
- | abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment closed: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - Jul 9, 2015
P2, N=48, Active, not recruiting, Sponsor: AstraZeneca
N=48 --> 59 Recruiting --> Active, not recruiting
- || abrilumab (AMG 181) / Amgen, AstraZeneca
Trial primary completion date: Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - Jun 23, 2015
P2, N=254, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Trial primary completion date: May 2015 --> Dec 2014
- ||| abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment closed: Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Jun 23, 2015
P2, N=359, Active, not recruiting, Sponsor: Amgen
Trial primary completion date: May 2015 --> Dec 2014 Recruiting --> Active, not recruiting
- ||| abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment closed: Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - Jan 15, 2015
P2, N=254, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- abrilumab (AMG 181) / Amgen, AstraZeneca
Trial primary completion date: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - Dec 5, 2014
P2, N=48, Recruiting, Sponsor: AstraZeneca
Recruiting --> Active, not recruiting Trial primary completion date: Feb 2015 --> Aug 2015
- | abrilumab (AMG 181) / Amgen, AstraZeneca
Trial completion: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. (clinicaltrials.gov) - Jul 14, 2014
P1, N=43, Completed, Sponsor: Amgen
Trial primary completion date: Feb 2015 --> Aug 2015 Active, not recruiting --> Completed
- || abrilumab (AMG 181) / Amgen, AstraZeneca
Trial primary completion date: Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - May 28, 2014
P2, N=252, Recruiting, Sponsor: Amgen
Active, not recruiting --> Completed Trial primary completion date: Dec 2014 --> May 2015
- || abrilumab (AMG 181) / Amgen, AstraZeneca
Trial primary completion date: Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - May 28, 2014
P2, N=360, Recruiting, Sponsor: Amgen
Trial primary completion date: Dec 2014 --> May 2015 Trial primary completion date: May 2017 --> Feb 2015
- || abrilumab (AMG 181) / Amgen, AstraZeneca
Trial primary completion date: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - May 15, 2014
P2, N=53, Recruiting, Sponsor: AstraZeneca
Trial primary completion date: May 2017 --> Feb 2015 Trial primary completion date: Oct 2014 --> Feb 2015
- || abrilumab (AMG 181) / Amgen, AstraZeneca
Trial completion date: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - May 15, 2014
P2, N=53, Recruiting, Sponsor: AstraZeneca
Trial primary completion date: Oct 2014 --> Feb 2015 Trial completion date: Jun 2017 --> Oct 2017
- |||| abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment open: Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Feb 2, 2014
P2, N=360, Recruiting, Sponsor: Amgen
Trial completion date: Jun 2017 --> Oct 2017 Suspended --> Recruiting
- |||| abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment open: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - Jan 27, 2014
P2, N=53, Recruiting, Sponsor: AstraZeneca
Suspended --> Recruiting Not yet recruiting --> Recruiting
- |||| abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment open: Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - Jan 8, 2014
P2, N=252, Recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Suspended --> Recruiting
- abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment change: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. (clinicaltrials.gov) - Jan 7, 2014
P1, N=43, Active, not recruiting, Sponsor: Amgen
Suspended --> Recruiting N=64 --> 43
- abrilumab (AMG 181) / Amgen, AstraZeneca
Enrollment closed: Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. (clinicaltrials.gov) - Jan 7, 2014
P1, N=43, Active, not recruiting, Sponsor: Amgen
N=64 --> 43 Recruiting --> Active, not recruiting
- ||||| abrilumab (AMG 181) / Amgen, AstraZeneca
New P2 trial: MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (clinicaltrials.gov) - Oct 7, 2013
P2, N=53, Recruiting, Sponsor: AstraZeneca
- abrilumab (AMG 181) / Amgen, AstraZeneca
Trial termination: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - Jul 22, 2013
P1, N=72, Terminated, Sponsor: Amgen
Recruiting --> Active, not recruiting Recruiting --> Terminated
- ||||| abrilumab (AMG 181) / Amgen, AstraZeneca
New P2 trial: Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease (clinicaltrials.gov) - Sep 27, 2012
P2, N=252, Recruiting, Sponsor: Amgen
- ||||| abrilumab (AMG 181) / Amgen, AstraZeneca
New P2 trial: Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) - Sep 25, 2012
P2, N=360, Recruiting, Sponsor: Amgen