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CIT-013 is an investigational monoclonal antibody, a protein-based substance designed to bind to a specific target in the body. It is an anti-citrullinated histone monoclonal antibody, meaning it recognises and attaches to histones — proteins that package DNA inside cells — after they have undergone a chemical change called citrullination.[3] CIT-013 is being developed by Citryll B.V., a company based in Oss, the Netherlands.[3] It has no marketing authorisation in the registry records and remains an investigational medicine.
CIT-013 is described as a dual action therapeutic for neutrophil extracellular trap-associated autoimmune diseases.[3] Neutrophil extracellular traps, or NETs, are web-like structures released by certain immune cells called neutrophils. These traps can contain citrullinated histones, which may contribute to inflammation and autoimmunity in several diseases. By binding to citrullinated histones, CIT-013 is intended to interfere with this disease process.[3] The dual action refers to the antibody's ability to target these structures in more than one way, although the published description does not give further detail on the two mechanisms.
The clinical trial records list two conditions for which CIT-013 is being investigated:
In both registered trials, CIT-013 is given as a subcutaneous injection, meaning it is injected under the skin. The trials use two dose levels: 50 mg and 100 mg.[2][1] The placebo used for comparison is a commercially available sodium chloride 0.9% solution in water, also given by subcutaneous injection.[2] No pharmaceutical form other than the injectable solution appears in the registry records.
Two Phase 2 trials of CIT-013 are registered, both authorised but not yet reporting results. The trials are summarised in the table below.
In the hidradenitis suppurativa trial, the primary outcome is the proportion of participants achieving HiSCR75 at day 85. HiSCR75 stands for Hidradenitis Suppurativa Clinical Response 75, meaning at least a 75% reduction in the number of inflammatory lesions without an increase in abscesses or draining tunnels. The analysis pools the two CIT-013 dose groups and compares them with placebo.[2]
In the rheumatoid arthritis trial, the primary endpoint is the mean change in DAS28-CRP from baseline to day 43. DAS28-CRP is a disease activity score that combines counts of tender and swollen joints, a blood marker of inflammation called C-reactive protein (CRP), and the patient's own assessment of disease activity. The two CIT-013 dose arms are pooled and compared with placebo.[1]
The hidradenitis suppurativa trial enrols adults with moderate to severe hidradenitis suppurativa and plans to include 96 participants.[2] The rheumatoid arthritis trial enrols adults with moderately active rheumatoid arthritis and plans to include 88 participants.[1] Both trials are randomised, double-blind and placebo-controlled, meaning participants are assigned by chance to receive CIT-013 or placebo, and neither the participants nor the researchers know which treatment is given until the trial is unblinded.
The provided source does not report side effects for CIT-013. Because the trials are still in early clinical development and no results have been published in the registry records, no side effect information is available on this page.
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