Clinical Trials

Inclusion Criteria:

1. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301;
participants prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons
other than safety or toxicity can be included at the discretion of the Investigator after
completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments.

Exclusion Criteria:

1. Anticipated use of another investigational agent for any condition during the course
of the trial.

2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except
successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in
situ).

3. Women of childbearing potential (WOCBP) or male participants not agreeing to use
highly effective method(s) of birth control throughout the trial and for 4 weeks after
last dose of trial drug as defined in the protocol.

4. Any new development with the participant's disease or condition or any significant
laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the
opinion of the Investigator, would potentially put the subject at unacceptable risk.

5. Pregnant or lactating women.

6. Participants will be ineligible if, in the opinion of the Investigator, they are
unlikely to comply with the trial protocol or have a concomitant disease or condition
that could interfere with the conduct of the trial.

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

Eligibility last updated 12/7/23. Questions regarding updates should be directed to the study team contact.