Lutikizumab for Atopic Dermatitis

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: AbbVie

Disqualifiers: Malignancy, Active skin disease, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort. The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD. Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis. Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US. In Sub-Study 1 HS participants will receive subcutaneous (SC) injections of lutikizumab for up to week 15 with a 70-day follow-up period. In Sub-Study 2 AD, participants will receive subcutaneous (SC) injections of lutikizumab for up to week 14 with a 70-day follow-up period. The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks. Participants in Sub-Study 1 (HS) who complete Week 16 and showed a therapeutic benefit to lutikizumab, as confirmed by the investigator, will have the option to enter an open-label long-term extension (LTE) to continue to receive lutikizumab for up to an additional 140 weeks, followed by a 70-day follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be naïve to biologic treatments or have had an inadequate response to certain therapies, which might imply some restrictions. It's best to discuss your specific medications with the trial team.

Eligibility Criteria

Adults with moderate to severe Hidradenitis Suppurativa (HS) or Atopic Dermatitis (AD), also known as eczema, can join this study. Participants will receive injections of a new drug called Lutikizumab and must be willing to undergo frequent medical assessments and tests.

Inclusion Criteria

I have never had biologic treatment for AD or didn't respond well to dupilumab after 8 weeks.

I have had moderate-to-severe hidradenitis suppurativa for at least 6 months.

I have had moderate-to-severe atopic dermatitis for at least a year.

+1 more

Exclusion Criteria

I do not have a skin condition that could affect the study's assessment.

I haven't had any cancer except for skin cancer or localized cervical cancer in the last 5 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of lutikizumab for up to 15 weeks in Sub-Study 1 and up to 14 weeks in Sub-Study 2

14-15 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Open-label extension (optional)

Participants in Sub-Study 1 who show therapeutic benefit may continue to receive lutikizumab for up to an additional 140 weeks

140 weeks

Participant Groups

The trial is testing the effects of Lutikizumab on skin diseases HS and AD. It's divided into two parts: one for HS patients receiving injections up to week 15, another for AD patients up to week 14, followed by a follow-up period.

4Treatment groups

Experimental Treatment

Group I: SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïveExperimental Treatment1 Intervention

AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.

Group II: SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR)Experimental Treatment1 Intervention

AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.

Group III: SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-NaïveExperimental Treatment1 Intervention

HS Bio-naïve participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration, with the option to enter an open-label LTE to continue to receive Lutikizumab Dose B at Week 16 and every week thereafter.

Group IV: SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate ResponseExperimental Treatment1 Intervention

Tumor Necrosis Factor-Inadequate Response (TNF-IR) participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration.