Trial · NCT06205121
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response to treatment | After 12 weeks of treatment, i.e. from baseline (randomization) visit to End-of-Treatment (EOT) visit. | Response classed as Complete response, Partial response, Stable disease and Progressive disease based on Standard Uptake Volume (SUV) changes in the uptake for {18F\]FDG-PET/CT above the background (pulmonary parenchyma /ascending aorta) in pulmonary target lesions and any new lesions. |
| Secondary | Total granulomatous inflammation evaluation | After 12 weeks of treatment, i.e. from baseline (randomization) visit to EOT visit. | Evaluation by \[18F\]FDG PET/CT imaging, quantified as the percent change of maximum, mean, peak SUV (SUVmax, SUVmean, SUVpeak), and volume of the lesions in pulmonary parenchyma, mediastinal/hilar nodes, and extrathoracic locations. |
| Secondary | Pulmonary function Forced Vital Capacity (FVC) | At Screening visit and over 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT). | Absolute change in FVC (% predicted). |
| Secondary | Pulmonary function Forced Expiratory Volume in the first second (FEV1) | At Screening visit and over 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT). | Absolute change in FEV1 (% predicted). |
| Secondary | Quality of life assessment | Assessed at baseline (randomization) visit and after 12 weeks of treatment (EOT visit) or study participation (week 12 visit). | Change in the quality of life measured by the Kings Sarcoidosis Questionnaire General and Lung (KSQ GENERAL and LUNG) scores. Range of each module 0-100, 100= best health status. |
| Secondary | Fatigue Assessment Scale (FAS) | Assessed at baseline (randomization) visit and after 12 weeks of treatment (EOT visit) or study participation (week 12 visit). | Change in FAS total score. Range: 10 (no fatigue) - 50 (extreme fatigue). |
| Secondary | Adverse events | Recorded from the time of signature of informed consent and until 30 days after the last dose of OATD-01/Placebo. | Occurrence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events, Adverse Events of Special Interest (AESIs), TEAEs leading to discontinuation and TEAEs leading to death. |
| Secondary | Laboratory tests | Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8 and week 12 (EOT). | Occurrence of clinically significant laboratory (hematology and biochemistry) parameter abnormalities (number of subjects with clinically significant abnormal laboratory values). |
| Secondary | Vital signs - Systolic Blood Pressure | Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any Follow-up (UP) visits | Mean change in Systolic Blood Pressure. |
| Secondary | Vital signs - Diastolic Blood Pressure | Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits. | Mean change in Diastolic Blood Pressure. |
| Secondary | Vital signs | Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits. | Mean change in Heart Rate. |
| Secondary | Vital signs - Respiratory Rate | Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits | Mean change in Respiratory Rate |
| Secondary | Electrocardiography | 12-lead-ECG measured at screening and over 12 weeks of treatment or study participation - at randomization visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits. 2-week 24-h-ECG recordings at weeks 0, 4 and 8 post randomization. | Occurrence of any clinically significant abnormalities (number of patients with any clinically significant Heart rhythm, PR Interval, QTcF interval or QRS width interval abnormalities) in 12-lead electrocardiography (ECG) or 24-h ECG. |
| Secondary | Electrocardiography - specific parameters | Measured at screening and over 12 weeks of treatment or study participation - at baseline (randomization) visit, at week 2 of treatment, week 4, week 8, week 12 (EOT) and any FUP visits. | Occurrence of: a) QTcF \>450 ms (male), \>470 ms (female) and \>500 ms (any sex) b) Change from baseline in QTcF \>30 ms and \>60 ms c) Heart rhythm abnormalities including supraventricular arrhythmias, ventricular arrhythmias, and non-sustained ventricular tachycardias. |
| Secondary | Male fertility | Measured at baseline (randomization) visit and at week 8 or week 12 (EOT) of treatment. | Occurrence of a clinically significant abnormality of sperm parameters and/ or free testosterone concentration in males (optional testing) |
| Secondary | Neurological status | TEAEs detected during 12 weeks of treatment or study participation - from baseline (randomization) visit and up to FUP visit 7-10 days after last dose | Occurrence of TEAEs of sensation abnormalities or ataxia. |
| Secondary | Thyroid and renal function | Clinically significant abnormalities detected during 12 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT). | Proportion of subjects with clinically significant thyroid parameters (Thyroid Stimulating Hormone \[TSH\], Free Triiodothyronine \[FT3\], and Free Thyroxine \[FT4\] and renal function parameters \[blood urea nitrogen (BUN)/total urea, creatinine, creatinine clearance (CrCL)\]. |
| Secondary | Pharmacokinetics assessment | Measured during 2 weeks of treatment - at baseline (randomization) visit, at week 4 of treatment, week 8 and week 12 (EOT). | Mean plasma OATD-01 concentrations. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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