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A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis

ConditionPulmonary Sarcoidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXentria, Inc.

About this trial

A phase 1b/2 study of XTMAB-16 in patients with pulmonary sarcoidosis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant between 18 to 80 years (inclusive) of age.

Weighs between 45 kg and 160 kg (99 to 353 lbs) at Screening.

Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the WASOG criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).

Modified Medical Research Conference (mMRC) Dyspnea Scale of ≥ 1.

Disqualifiers

Pregnant or breastfeeding women or women who are planning to become pregnant during the study.

PART A ONLY: Participants > 65 years of age. (This exclusion criterion is only applicable for EU).

PART A ONLY: Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by high-resolution computed tomography (HRCT), confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included.

PART A ONLY: Any prior TNFα inhibitor therapy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • XTMAB-16 or Placebo

    Drug

    Infusion

Treatment groups

94 Participants
are divided into 5 treatment groups
Group A: Part A - XTMAB-16: 2 mg/kg every 4 weeks (Q4W) for 12 weeks or PlaceboExperimental treatment 1 intervention
Group B: Part A - XTMAB-16: 4 mg/kg every 4 weeks (Q4W) for 12 weeks or PlaceboExperimental treatment 1 intervention
Group C: Part A - XTMAB-16: 2 mg/kg every 2 weeks (Q2W) for 12 weeks or PlaceboExperimental treatment 1 intervention
Group D: Part A - XTMAB-16: 4 mg/kg every 2 weeks (Q2W) for 12 weeks or PlaceboExperimental treatment 1 intervention
Group E: Part B - XTMAB-16 (dose established in Part A) for 24 weeks or PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Adverse Events, including Serious Adverse Events, Dose Limiting Toxicities, and Adverse Events of Special Interest throughout the study duration

Safety and Tolerability

Time frame
Throughout Study Duration, 20 weeks (Part A)

Secondary outcomes

1

Proportion of participants who achieve the targeted tapered dose of corticosteroid

Efficacy

Time frame
Baseline to Week 12 (Part A)
2

Proportion of participants who achieve at least 50% reduction in dose of corticosteroid by Week 12

Efficacy

Time frame
Baseline to Week 12 (Part A and B)
3

Proportion of patients able to maintain steroid reduction through Week 24

Efficacy

Time frame
Week 12 to Week 24 (Part B)
4

Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs) throughout the study duration

Safety

Time frame
Throughout Study Duration, 34 weeks (Part B)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xentria, Inc.

Lead sponsor

Source ClinicalTrials.gov
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