Phase 2 Psoriasis Trial, Completed NCT04015518 Sponsor: Boehringer Ingelheim Condition: Psoriasis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called spesolimab as a treatment for palmoplantar pustulosis (PPP) — a skin condition that causes painful blisters and pustules on the palms of the hands and soles of the feet. A total of 152 people took part, divided into five groups: one group received a placebo (a dummy treatment with no active medicine), and four groups received different doses of spesolimab. The trial's main goal was to measure how much a scoring system called the PPP ASI — which rates the severity of the skin condition on a scale from 0 (no disease) to 72 (worst possible) — changed from the start of the trial to week 16. The reported data shows that all five groups, including the placebo group, had lower PPP ASI scores at week 16 compared to where they started. The placebo group's score decreased by about 33.6%, while the four spesolimab dose groups saw decreases of approximately 44.2%, 48.3%, 46.2%, and 38.9% respectively. For pain (measured on a scale of 0 to 10, where 0 means no pain and 10 means very severe pain), the reported data shows all groups also had lower pain scores at both week 4 and week 16 compared to baseline. Regarding the number of people whose PPP ASI score dropped by at least 50% by week 16, the reported data shows this occurred in 12 participants in the placebo group, compared to 7, 10, 12, and 18 participants across the four spesolimab dose groups. For a 75% drop in score, the numbers were 3 in the placebo group and 3, 6, 4, and 9 across the spesolimab groups. It is also worth noting that not everyone completed the trial — for example, 11 out of 43 people in the placebo group and 12 out of 44 in the highest-dose spesolimab group did not finish the study, though the reasons were not detailed in the reported data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Psoriasis Trial, Completed

NCT04015518
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 75 years old at the time of screening
  • You have been diagnosed with Palmoplantar Pustulosis (PPP), meaning you have had visible, non-infected blisters/pustules on your palms and/or soles for more than 3 months, with or without psoriasis on other parts of your body
  • Your PPP is rated as at least "moderate" in severity based on a doctor's assessment at both screening and the start of the trial
  • Your PPP scores at least 12 on a specific skin severity scale (called PPP ASI) at both screening and the start of the trial (confirm with trial site)
  • You are male or female; if you are a woman who could become pregnant, you must be willing and able to use a highly effective form of contraception during the trial
  • You are willing to sign a consent form agreeing to take part in the trial

Who may not be able to join:

  • Women who are currently pregnant, breastfeeding, or planning to become pregnant during the trial
  • People with serious, worsening, or poorly controlled conditions affecting the kidneys, liver, blood, hormones, lungs, heart, nervous system, brain, or mental health
  • People who have a history of, or currently have, PPP-like disease that was triggered by a specific type of medication called anti-TNF drugs (confirm with trial site)
  • People who have received an organ transplant (except a corneal/eye transplant received more than 12 weeks before screening) or have ever received stem cell therapy
  • People with a known history of, or signs suggesting, diseases involving abnormal growth of lymph cells, such as lymphoma or swollen lymph nodes/spleen

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Paratus Clinical Research Woden, Phillip, Australian Capital Territory
Westmead Hospital, Westmead, New South Wales
Veracity Clinical Research, Wooloongabba, Queensland
Skin Health Institute Inc, Carlton, Victoria
Royal Melbourne Hospital, Parkville, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
31 July 2019
Est. completion
6 August 2020

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov