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Adalimumab, Doxycycline, and Resorcinol for Adults with Early Hidradenitis Suppurativa at High Risk of Progression to Severe Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Hidradenitis suppurativa is a long‑lasting skin condition that causes painful, inflamed lumps under the skin, often in areas such as the armpits or groin. In this study the medicine adalimumab, given as a small injection under the skin, is being tested against the usual treatment of the antibiotic doxycycline taken by mouth. Both groups may also use a topical cream containing Resorcinol as part of standard skin care.

The purpose of the trial is to find out whether early use of adalimumab can lower the chance that the condition becomes severe disease compared with standard care. Participants who have non‑severe Hidradenitis suppurativa but are considered at high risk for worsening are randomly assigned to receive either the injection or the antibiotic. The study follows them for about two years, with regular clinic visits to check the skin and overall health. “Severe disease” is defined by either a classification called Hurley stage 3, which means many connected tunnels and lumps across the affected area, or an IHS4 score of 11 or higher, a simple tally of the number of nodules, abscesses and tunnels.

After an initial screening, participants start their assigned treatment and continue it for up to 104 weeks, returning to the clinic at set intervals for safety checks and to monitor any changes in their skin condition. The study does not involve any additional procedures beyond these routine visits.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit and randomization
After joining the study, you will attend a baseline visit (week 0) where your health status and severity of hidradenitis suppurativa are recorded.
Based on the recorded information, you will be assigned to one of two groups: the adalimumab group or the doxycycline (standard of care) group.
Step 2
Start of medication
If assigned to the adalimumab group, you will receive a subcutaneous injection of 160 mg adalimumab. the injection is given under the skin according to the study schedule.
If assigned to the doxycycline group, you will take oral doxycycline 200 mg. the tablets are taken as directed by the study protocol.
Step 3
Regular medication use
Throughout the 104‑week study period, you will continue to receive the assigned medication.
The adalimumab injection will be administered at the intervals specified by the study, and the doxycycline tablets will be taken at the same frequency as instructed.
In addition, you may apply resorcinol cream (0.41 g) to the affected skin areas as part of the background treatment.
Step 4
Follow‑up visits
You will attend scheduled clinic visits approximately every few weeks or months, up to a total of ten visits, with the final visit occurring at week 104.
During each visit, your disease status will be evaluated to determine whether severe hidradenitis suppurativa has developed.
Step 5
Final assessment
At the week 104 visit, a final assessment will be performed to record whether the disease progressed to severe stage.
The results will be used to compare the outcomes between the adalimumab group and the doxycycline group.

Who can join the trial?

27 criteria

Must be able to understand written and spoken Danish.
Must have a diagnosis of hidradenitis suppurativa confirmed by a skin doctor (dermatologist) or by the study doctor at the first visit.
Must be judged to have a high chance of the disease becoming severe, based on a special risk algorithm.
Must have at least one active skin sore or lump from hidradenitis suppurativa when screened and at the start of the study.
Must have an IHS4 score (a number that measures how bad the disease is) lower than 11 and a Hurley stage (a way doctors classify severity) lower than 3.
Blood test must show hemoglobin (the protein that carries oxygen) within the normal range for your sex.
Blood test must show leukocytes (white blood cells that fight infection) within the normal range.
Blood test must show C‑reactive protein (a marker of inflammation) less than 10 mg/L.
Blood test must show thrombocytes (platelets that help blood clot) within the normal range.
Blood test must show alanine transaminase (a liver enzyme) within the normal range.
Blood test must show aspartate transaminase (another liver enzyme) within the normal range.
Blood test must show alkaline phosphatase (an enzyme related to liver and bone) within the normal range.
Blood test must show bilirubin (a substance from broken‑down red blood cells) within the normal range.
Blood test must show creatinine (a measure of kidney function) within the normal range.
Blood test must show sodium and potassium (electrolytes that help nerves work) within the normal range.
Tests for hepatitis B must be negative (no infection).
Tests for hepatitis C must be negative (no infection).
Test for varicella‑zoster virus (chicken‑pox/shingles) must show immunity (IgG positive).
Test for antinuclear antibodies must be negative (no autoimmune activity).
Test for human immunodeficiency virus (HIV) must be negative.
Test for tuberculosis (TB) must be negative (IGRA test).
Must never have received a biological treatment (a special type of drug that targets the immune system) for hidradenitis suppurativa before.
Must be a patient at Gentofte Hospital.
Must sign an informed consent form, showing you understand and agree to join the study.
Must be able to answer questionnaire questions on your own (cognitively intact).
If you are a woman who could become pregnant, you must agree to use a highly effective birth control method during the study and for at least 12 weeks after the last dose.
Must be older than 18 years.

Who cannot join the trial?

19 criteria

Allergy or strong reaction to any ingredient in the standard of care (SOC) medication or in Adalimumab.
Any condition that makes taking Adalimumab unsafe, such as a current serious infection, moderate to severe heart failure (NYHA class III or IV), receiving a live vaccine within the past 3 months, or a history of diseases that damage nerve coverings (demyelinating neurological disease).
Using another immune‑system‑blocking drug (called a biological agent) at the same time, such as Anakinra, Ixekizumab, Secukinumab, or Ustekinumab.
Having taken a systemic (body‑wide) treatment for HS recently without a wash‑out period (the time needed for the drug to leave the body, usually five half‑lives).
Using any topical (skin‑applied) medication for HS while in the study.
Abnormal chest X‑ray that shows signs of granulomatous disease (a type of inflammation that creates small nodules), cancer, chronic lung problems like moderate to severe scarring of lung tissue (pulmonary fibrosis), emphysema, heart problems, or fluid around the lungs (pleural effusion).
History of cancer, except for skin cancers that are not melanoma.
Blood test results that are outside the normal range for things such as hemoglobin (Hb), white blood cells (Leu+ Diff), inflammation marker (CRP), platelets (Trc), liver enzymes (ALAT, ASAT), blood pressure (BP), blood flow (BF), kidney function (creatinine), sodium (Na), potassium (K), and tests for infections like hepatitis B, hepatitis C, varicella‑zoster virus (VZV), antinuclear antibodies (ANA), or HIV.
Positive test for tuberculosis (TB), a serious lung infection.
Being judged at low risk of progressing to severe HS according to the study’s risk algorithm.
Having severe HS classified as Hurley Stage III.
Having an IHS4 score of 11 or higher (a scoring system that measures disease severity).
Having already received a biological treatment for HS, such as Adalimumab, Anakinra, Ixekizumab, Secukinumab, or Ustekinumab.
Being pregnant.
Breastfeeding.
Planning to become pregnant at any time during the two‑year study period.
Planning to have surgery on the HS‑affected areas during the study.
Having other health problems that the doctor believes make participation unsafe.
Being unable to give informed consent (the ability to understand the study and agree to take part).

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Gentofte Hospital
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Hellerup, Denmark

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Investigated drugs

Doxycycline
is an oral antibiotic that is commonly used as the usual treatment for mild to moderate hidradenitis suppurativa. In this study it serves as the standard of care that the new therapy is compared against. Participants take the medicine by mouth, and it works by reducing bacteria and inflammation in the skin.
Adalimumab
is a biologic medication given by subcutaneous injection. It belongs to a class of drugs that block a protein called tumor necrosis factor‑alpha (TNF‑α), which helps to reduce the inflammation that drives hidradenitis suppurativa. In the trial this drug is the experimental treatment being tested to see if it can prevent the disease from becoming severe.
Resorcinol
is a topical cream applied directly to the skin. It is used in the study as background therapy for all participants. The cream helps to clean the affected areas and can reduce inflammation and bacterial growth on the skin surface.

What is already known about the treatment

DOXYCYCLINE
Doxycycline is taken as a 200 mg oral tablet that you swallow with water. It is an approved antibiotic that has been studied for many years and is listed in standard medical references. It is mainly used to treat bacterial infections such as acne, respiratory infections, and certain skin conditions. It works by attaching to a part of the bacterial cell that makes proteins, stopping the bacteria from growing, and it belongs to the tetracycline class of antibiotics.
ADALIMUMAB
Adalimumab is given as a 160 mg subcutaneous injection, meaning it is injected under the skin using a pre‑filled pen. It is an approved biologic medicine that has been extensively studied and is listed in major medical guidelines. It is used to treat moderate to severe hidradenitis suppurativa as well as other inflammatory conditions like rheumatoid arthritis and Crohn’s disease. It works by binding to a protein called tumor necrosis factor‑alpha (TNF‑α) and blocking its activity, which reduces inflammation, and it belongs to the class of TNF‑alpha inhibitor monoclonal antibodies.
RESORCINOL
Resorcinol is applied as a cream that is rubbed onto the skin, with a typical amount of about 0.41 g per dose. It is an over‑the‑counter topical agent that has been used for many years and appears in standard dermatology references. It is mainly used to treat skin problems such as acne, warts, and as a supporting treatment for hidradenitis suppurativa. It works by gently breaking down dead skin cells and having mild antiseptic effects, and it is classified as a phenolic keratolytic and antiseptic.

Investigated diseases

Hidradenitis suppurativa - Hidradenitis suppurativa is a chronic skin condition that causes painful lumps under the skin, often in areas where skin rubs together such as the armpits, groin, and under the breasts. The lumps begin as small, inflamed bumps that can break open and drain pus. Over time, repeated episodes can create tunnels (sinus tracts) that connect the lesions. The disease can progress from mild forms with few isolated bumps to more extensive involvement with many interconnected lesions. As it advances, the skin may become scarred and thickened.