Adrenomedullin for biologic-resistant Crohn's disease: A randomized, double-blind, placebo-controlled phase 2a clinical trial

What Was Tested

This randomized controlled trial paper looks at Adrenomedullin.

Adrenomedullin is a bioactive peptide with many pleiotropic effects, including mucosal healing and immunomodulation.

Who Took Part

The abstract describes 24 patients taking part.

This was a multicenter, double-blind, placebo-controlled phase 2a trial that evaluated 24 patients with biologic-resistant CD in Japan.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

The patients were allocated by chance, so the Adrenomedullin group and the comparison group should start out alike.

Neither the patients nor the staff measuring them knew who was on Adrenomedullin, so expectations could not easily colour the readings.

Some patients received a placebo instead of Adrenomedullin, giving a reference point.

More than one site took part, so the patients came from several places.

The primary endpoint was the change in the CD activity index (CDAI) at 8 weeks.

The main secondary endpoints included changes in CDAI from week 4 to week 24.

What Was Measured

The subject headings attached to it are Crohn Disease, Adrenomedullin, Biological Products and Japan.

The authors tagged it with the keywords Crohn's disease, Japanese and phase 2a clinical trial.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Adrenomedullin in 24 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2022 (Journal of gastroenterology and hepatology), a journal based in Australia.

More context: the Adrenomedullin compound page, all human trials.