The Phase llb trial includes around 300 adults with symptomatic haemorrhoids. Credit: Nephron / commons.wikimedia.org.

Citius Pharmaceuticals has concluded enrolment of patients in its Phase llb trial of Halo-Lido (CITI-002) for the treatment of haemorrhoids, a gastrointestinal disorder.

CITI-002, which is a topical formulation to treat haemorrhoids, is yet to receive approval from the US Food and Drug Administration (FDA).

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The Phase llb trial includes around 300 adults, who have been diagnosed with symptomatic haemorrhoids.

The multi-centre, randomised, dose-ranging, double-blind, parallel group comparison study expects to publish topline data by the end of the second quarter of this year.

Its primary objective is the change in haemorrhoidal symptoms that the patients report post-treatment.

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The patients are keeping track of efficacy and safety data using a proprietary mobile-based Patient Reported Outcome (ePRO) tool.

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Following the publication of topline results, Citius Pharmaceuticals plans to initiate a Phase lll trial.

Citius Pharmaceuticals executive chairman Leonard Mazur said: “The study was fully enrolled within one year from initiation.

“We continue to believe that the global market for a prescription topical treatment for haemorrhoids is large and underserved.

“Contingent on the trial data, we expect to continue to advance this programme to maximise its value.”

In September last year, Citius Pharmaceuticals announced a clinical collaboration with the University of Pittsburgh for a Phase I/Ib study of I/ONTAK (denileukin diftitox or E7777) in combination with pembrolizumab to treat recurrent or metastatic solid tumours.