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Xtmab-16

Clinical trials are studying Xtmab-16 in people with pulmonary sarcoidosis, with or without disease outside the lungs. These studies are looking at safety, tolerability, dose selection, and whether Xtmab-16 can help reduce steroid use and improve lung-related outcomes.

Table of Contents

Trial overview

The clinical trials for Xtmab-16 are studying people with pulmonary sarcoidosis, with or without extrapulmonary manifestations.[1][2] One trial is a seamless phase 1b/2 study, and the other is a long-term phase 2 study.[1][2]

Who is being studied

The target population is patients with sarcoidosis in the lungs, and some participants may also have disease in other organs.[1][2] The source data list an enrollment of 94 participants for each study.[1][2]

This means the studies are not general studies in healthy volunteers. They are focused on people who already have the disease and who may need treatment that can help control symptoms and lower steroid use.[1]

Trial designs and phases

The first study, NCT05890729, is described as a seamless phase 1b/2 study with multiple ascending doses and proof of concept.[1] “Multiple ascending dose” means different dose levels are tested, one after another, to learn more about safety and the best dose.[1] “Proof of concept” means the study is also looking for early signs that the treatment may help.[1]

The second study, NCT06169397, is a long-term multicenter open-label phase 2 study.[2] “Open-label” means both the study team and the participants know what treatment is being given.[2] “Multicenter” means the study is carried out at more than one study site.[2]

The phase 1b/2 study also includes a comparison with placebo and oral steroid treatment in the source data.[1] Placebo means a look-alike treatment with no Xtmab-16, used to help compare results.[1]

What the trials measure

The main safety measures in the studies are adverse events, serious adverse events, dose-limiting toxicities, and adverse events of special interest.[1][2] These are medical problems that happen during the study and are tracked closely to understand safety.[1][2]

The phase 1b/2 study also measures pharmacokinetics, which describes how the body handles the treatment, including trough level, maximum level, average level, and area under the curve.[1] It also measures pharmacodynamics, which are body changes linked to treatment, including ACE, soluble IL-2 receptor, C-reactive protein, interleukin-1b, and calcitriol.[1]

Other phase 1b/2 measures include anti-drug antibodies, which are immune proteins that may react against the treatment, and whether corticosteroid dose can be reduced.[1] The study also tracks quality of life and lung-related outcomes, including forced vital capacity, King’s Sarcoidosis Questionnaire scores, Leicester Cough Questionnaire, and Steroid Toxicity Questionnaire results.[1]

The long-term phase 2 study mainly measures the rate of adverse events, serious adverse events, and adverse events of special interest over time.[2] Its brief summary says it is designed to evaluate long-term safety and tolerability of Xtmab-16.[2]

For efficacy, the phase 1b/2 study looks at whether participants can reach a target tapered dose of corticosteroid, specifically prednisone 5 mg/day or an equivalent dose, by Week 12.[1] This is important because lowering steroid use may reduce steroid-related burden in patients who need long-term treatment.[1]

Trial status and enrollment

Both studies are listed as Authorised in the source data, although the phase 1b/2 trial entry also includes a withdrawn record for the same NCT number.[1][2] The enrollment number shown for each trial is 94 participants.[1][2]

Overall, the trial program for Xtmab-16 is focused on early testing, dose finding, long-term safety, and whether the treatment may help patients reduce corticosteroid use while also tracking lung and quality-of-life outcomes.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05890729 Phase 1 Pulmonary sarcoidosis with or without extrapulmonary manifestations Authorised / Withdrawn 94
NCT06169397 Phase 2 Pulmonary sarcoidosis with or without extrapulmonary manifestations Authorised 94

FAQ

  • What condition are the Xtmab-16 trials studying? The trials are studying pulmonary sarcoidosis, which is sarcoidosis in the lungs. Some participants may also have extrapulmonary manifestations, meaning the disease is also present outside the lungs.
  • What is the main goal of the Xtmab-16 studies? The main goals are to check safety, tolerability, and the best dose and dosing frequency. The studies also look at whether Xtmab-16 can help reduce corticosteroid use and improve lung-related outcomes.
  • What phases are the Xtmab-16 trials in? One study is a seamless phase 1b/2 trial, and another is a phase 2 long-term study. The phase 1b/2 study includes early testing and proof of concept, which means it checks whether the treatment seems promising.
  • Who can take part in these trials? The trials are for patients with pulmonary sarcoidosis, with or without extrapulmonary manifestations. Enrollment in the source data is 94 participants for each study.
  • What outcomes are the trials measuring? The studies measure adverse events, serious adverse events, dose-limiting toxicities, and special safety concerns. They also measure drug levels in the body, immune markers, lung function, quality of life, and the ability to taper prednisone to 5 mg/day or an equivalent dose.

Ongoing Clinical Trials on Xtmab-16

  • Study of XTMAB-16 and Prednisolone Sodium Phosphate for Patients with Pulmonary Sarcoidosis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Italy Poland Spain

  • Study on the Effects of XTMAB-16 and Prednisolone in Patients with Pulmonary Sarcoidosis with or without Other Body Involvement

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Greece Italy Poland Spain

  • Study on Long-term Safety of XTMAB-16 for Patients with Pulmonary Sarcoidosis with or without Extra-pulmonary Involvement

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Italy Poland Spain

Glossary

  • Pulmonary sarcoidosis: A disease that causes inflammation in the lungs.
  • Extrapulmonary manifestations: Signs of the disease outside the lungs, such as in other organs.
  • Phase 1b/2: An early clinical trial stage that looks at safety, dose, and early signs that the treatment may work.
  • Open-label: A study design where participants and researchers know what treatment is being given.
  • Placebo: A look-alike treatment with no active Xtmab-16 in it, used for comparison.
  • Intravenous: Given through a vein, usually by infusion.
  • Adverse events: Unwanted medical problems that happen during a study.
  • Serious adverse events: More severe unwanted medical problems that may need urgent care or cause major harm.
  • Dose-limiting toxicities: Side effects that are serious enough to limit how much of a treatment can be given.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Pharmacodynamics: Changes in the body caused by the treatment, including marker changes.
  • Forced vital capacity (FVC): A lung function test that measures how much air a person can forcefully breathe out.

References