A Phase 2 interventional study of Lutikizumab in Hidradenitis Suppurativa and Atopic Dermatitis, sponsored by AbbVie. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by AbbVie · Phase 2, Interventional, and Basic science
Among 18 studies in Hidradenitis Suppurativa by AbbVie — 2 open to participants now, 5 under way, 2 of them phase 3. Hidradenitis Suppurativa · AbbVie.
Among the 18 studies in Hidradenitis Suppurativa by AbbVie, this one is the 10th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2024, is one of 4 in phase 2, and was the 17th registered.
285 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
Browse Hidradenitis Suppurativa studies →2 of the 18 studies in Hidradenitis Suppurativa by AbbVie are open now, in 12 countries. Recruiting first, the newest first:
AbbVie · Sites in Argentina, Canada, Colombia and 15 more countries
Ages 12+
By country, each count listing its studies:
Of the 61 Hidradenitis Suppurativa studies recruiting now, 33 (54%) set no upper age limit and 17 (28%) stop at 75 or younger; 13 take children under 18; 12 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 45 across 200 interventional studies indexed under Hidradenitis Suppurativa.
Median enrollment 243 across the 11 interventional studies, 106 across the 6 observational. Of the 12 that completed or were terminated, 8 (67%) have results posted.
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AbbVie is the lead sponsor of 976 studies on the registry; 135 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
3 of the studies in Hidradenitis Suppurativa by AbbVie that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06468228Phase 3AbbVieA Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa | 2026-12 |
| NCT06524635AbbVieA Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab | 2027-02 |
| NCT07136467AbbVieA Real World Study to Globally Assess Disease Burden in Adolescent and Adult Participants With Alopecia Areata, Vitiligo, or Hidradenitis Suppurativa | 2027-08 |
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Among the 18 studies in Hidradenitis Suppurativa by AbbVie, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Lutikizumab
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.
Drug: Lutikizumab
AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
Drug: Lutikizumab
AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
Drug: Lutikizumab
Subcutaneous (SC) Injection
Also known as: ABT-981
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 30 weeks
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
Started Aug 2024 (actual). Primary completion is estimated for Feb 2027, 30 months after the start.
Of 44 industry-sponsored phase 2 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's planned 30 months is above that.
Counting every sponsor, half of 54 studies reached it within 15 months; a quarter within 11 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Lutikizumab