Clinical Trials

Inclusion Criteria:

• Patients who completed treatment in the parent trials (1305-0014 or 1305-0023) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption).
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• Women of childbearing potential (WOCBP) ^1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information in Section 4.2.2.3. For France, fertile ^2 males must be ready and able to use acceptable methods of birth control; please refer to Section 4.2.2.3.
  • ^1 Note: Woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
  • ^2 Note: A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.

Exclusion Criteria:

• Any disease that may put the patient at risk when participating in this trial at investigator’s discretion.
• Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:
  • Any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour);
  • Any suicidal ideation of type 4 or 5 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
• Patients with clinically relevant severe depression at investigator’s discretion or a HADS subscore > 14 at Visit 1.
• An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
• Patient will undergo lung transplantation, with an assigned date of surgery.
• Patients with a BMI 10%) weight loss during the parent trial.
• At Visit 1, patients with ongoing AESI (suspected vasculitis, DILI, severe infections) that led to temporary treatment interruption in the parent trial.
• Patients who must or wish to take restricted medications (see Section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the trial.
• Patient not compliant in parent trial (1305-0014 or 1305-0023) with trial medication or trial visits, according to investigator’s judgement.
• Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator’s opinion, makes the patient an unreliable trial participant).
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• Previous enrolment in this trial.
• Participation in another interventional study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/13/23. Questions regarding updates should be directed to the study team contact.