Adalimumab for hidradenitis suppurativa that may become severe

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with hidradenitis suppurativa (HS) that is not severe but has a high risk of becoming severe. It compares adalimumab with standard care (doxycycline).

Age

Over 18 years, up to 64 years.

Sex

All sexes can join.

Disease stage

Non-severe HS with active lesions. IHS4 score < 11 and Hurley stage < 3. High risk of progressing to severe HS according to the risk algorithm.

Earlier treatment

No prior biological treatment for HS (for example Adalimumab, Anakinra, Ixekizumab, Secukinumab or Ustekinumab). Earlier whole-body HS treatment must have worn off. No current skin-applied HS treatment.

Biomarker or test result

Blood tests within set ranges. Negative for hepatitis B, hepatitis C, HIV, tuberculosis (IGRA) and ANA. Positive VZV IgG.

Main reasons for not taking part

• Ongoing infection, positive tuberculosis test, or moderate to severe heart failure (NYHA class III or IV)
• History of cancer other than non-melanoma skin cancer, or of demyelinating nerve disease
• Live vaccine within 3 months before the study drug
• Pregnancy, breastfeeding or plans to become pregnant during the two years
• Planned HS surgery in the treated areas

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 64 years old?YesNo

What the trial wants to find out

The primary objective is to answer the following research question: In adults with non-severe hidradenitis suppurativa (HS) but a high risk of progression to severe disease, does treatment with adalimumab, compared with standard of care (SOC [doxycycline]), reduce the proportion of patients who progress to severe disease over a 104-week period?