Phase 3 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who completed treatment in one of the related earlier trials (numbered 1305-0014, 1305-0023, or 1305-0035) without permanently stopping treatment early — temporary breaks from treatment are acceptable.
• People who have signed and dated a consent form agreeing to take part, in line with required guidelines.
• Women who could become pregnant must be willing and able to use highly effective contraception (less than 1% chance of failure per year when used correctly). If using the oral contraceptive pill, an additional barrier method such as a condom must also be used during sex, in case of severe vomiting or diarrhoea that could reduce the pill's effectiveness. (For people in France, men who are fertile must also be willing and able to use an accepted form of contraception.)

Who may not be able to join:

• People who have any illness that the trial doctor believes could put them at risk by participating.
• People who, at their first trial visit, show signs of suicidal behaviour (such as an actual attempt, interrupted attempt, aborted attempt, or preparatory actions) or certain types of suicidal thoughts as assessed by a standard scale called the C-SSRS — specifically, active thoughts of suicide with intent or with a specific plan.
• People who have severe depression considered clinically significant by the trial doctor, or who score above 14 on the depression section of a standard questionnaire called the Hospital Anxiety and Depression Scale (HADS), at their first trial visit.
• People who have been diagnosed with a cancer other than certain treated skin cancers (basal cell carcinoma or in situ squamous cell carcinoma of the skin) or treated early-stage cervical cancer, at their first trial visit.
• People who have a scheduled date for a lung transplant surgery.
• People with a Body Mass Index (BMI) below 18.5 kg/m² who also experienced an unexplained weight loss of more than 10% during the earlier related trial.
• People who, at their first trial visit, are still experiencing certain serious side effects from the earlier trial (specifically suspected vasculitis, drug-related liver injury, or severe infections — but not latent tuberculosis) that previously caused them to temporarily stop treatment.
• People who need to take, or wish to take, medications that are restricted or that are likely to interfere with the safe running of the trial.
• Additional exclusion criteria may also apply — the trial site can confirm these in full.

Important: Always verify eligibility with the trial site directly before applying.