In short
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.
Key points
- Xtmab-16 is being studied in clinical trials for pulmonary sarcoidosis, with or without disease outside the lungs. The source data show one seamless phase 1b/2 study and one long-term phase 2 study. The studies focus on safety, tolerability, dose selection, and whether Xtmab-16 can help reduce corticosteroid use. They also measure lung function, quality of life, immune markers, and drug levels in the body. The target population is adults with pulmonary sarcoidosis, including some with extrapulmonary manifestations. One study is authorised and another is long-term and open-label.
Trial overview
The clinical trials for Xtmab-16 are studying people with pulmonary sarcoidosis, with or without extrapulmonary manifestations. One trial is a seamless phase 1b/2 study, and the other is a long-term phase 2 study.
Who is being studied
The target population is patients with sarcoidosis in the lungs, and some participants may also have disease in other organs. The source data list an enrollment of 94 participants for each study.
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.
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. “Multiple ascending dose” means different dose levels are tested, one after another, to learn more about safety and the best dose. “Proof of concept” means the study is also looking for early signs that the treatment may help.
The second study, NCT06169397, is a long-term multicenter open-label phase 2 study. “Open-label” means both the study team and the participants know what treatment is being given. “Multicenter” means the study is carried out at more than one study site.
The phase 1b/2 study also includes a comparison with placebo and oral steroid treatment in the source data. Placebo means a look-alike treatment with no Xtmab-16, used to help compare results.
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. These are medical problems that happen during the study and are tracked closely to understand safety.
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. It also measures pharmacodynamics, which are body changes linked to treatment, including ACE, soluble IL-2 receptor, C-reactive protein, interleukin-1b, and calcitriol.
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. 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.
The long-term phase 2 study mainly measures the rate of adverse events, serious adverse events, and adverse events of special interest over time. Its brief summary says it is designed to evaluate long-term safety and tolerability of Xtmab-16.
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. This is important because lowering steroid use may reduce steroid-related burden in patients who need long-term treatment.
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. The enrollment number shown for each trial is 94 participants.
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.