Long-term safety and effectiveness of APG777 in moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind long-term extension enrolls participants who completed the treatment period in a prior APG777 parent study and who may benefit from continued therapy. The LTE includes a screening visit coinciding with the last maintenance visit of the parent study, an extended treatment period where participants continue APG777, and a post-treatment follow-up period. Participants continue the same non-prescription emollient they used in the parent study and are monitored for safety and efficacy outcomes and adverse events. Those with serious adverse events or who discontinued the parent study early are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol
* Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777
* Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study

Exclusion Criteria:

* Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient
* Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
* Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study
* Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments

Note: Additional protocol defined Inclusion/Exclusion criteria may apply

Where it's running

• Investigational Site
  Fountain Valley, California, United States Recruiting
• Investigational Site
  Los Angeles, California, United States Recruiting
• Investigational Site
  Coral Gables, Florida, United States Recruiting
• Investigational Site
  Jacksonville, Florida, United States Recruiting
• Investigational Site
  Margate, Florida, United States Recruiting
• Investigational Site
  Douglasville, Georgia, United States Recruiting

+30 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.