Table 2.
Overview of ongoing clinical trials of targeted therapy in palmoplantar pustulosis
| Drug name (conditions) | Study title | Design (no. of pts) | Dosage | Endpoints | Stage of clinical development (results) | Trial registration number |
|---|---|---|---|---|---|---|
| Anakinra (palmoplantar pustulosis) | APRICOT: Anakinra for pustular psoriasis [117] | Phase IV, two-stage, adaptive, double-blind, randomized, PL-controlled trial (n = 64) | SC 100 mg daily for 8 wk |
Primary outcome measures: Fresh pustule count on palms and soles across 1, 4, and 8 wk or PPPASI across 1, 4, and 8 wk Secondary outcome measures: Fresh pustule count on palms and soles or PPPASI. Total pustule count on palms and soles across wk 1, 4, and 8 adjusted for baseline. PPIGA at wk 1, 4, and 8 adjusted for baseline. Time to response of PPP (75% reduction in fresh pustule count), time to relapse, time to achievement of “clear” on PPIGA by 8 wk, development of disease flare (> 50% deterioration in PPPASI), pustular psoriasis at nonacral sites (not hands and feet) as measured by percentage area of involvement at 8 wk, plaque-type psoriasis (if present) measured using PASI at 8 wk |
Recruiting (no results posted) | ISRCTN13127147 |
| Anakinra (Sneddon-Wilkinson; acrodermatitis continua of Hallopeau; pustular psoriasis; palmoplantar pustulosis) | Anakinra for Inflammatory Pustular Skin Diseases | Phase II study (n = 30) | SC 100 mg daily up to 200 mg at wk 4 | Primary outcome measures: ≥ 50% improvement in TBSAI at wk 12 | Recruiting (no results posted) | NCT01794117 |
| ANB019 (palmoplantar pustulosis) | A Study to Evaluate the Efficacy and Safety of ANB019 in Subjects with Palmoplantar Pustulosis [118] | Phase II, randomized, PL-controlled, double-blind, multiple-dose study (n = 50) | SC every 4 wk |
Primary outcome measures: Number of subjects with PPPASI 50 at wk 16. Number of participants with AEs at wk 24 Secondary outcome measures: Change from baseline in PPSI, PPIGA, DLQI at wk 16. Determination of pharmacokinetics of ANB019 in pts with palmoplantar pustulosis (serum concentration) at wk 24 |
Recruiting (no results posted) | NCT03633396 |
| BI 655130/spesolimab (palmoplantar pustulosis) | Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients [119] | Phase IIa, multicenter, double-blind, randomized, PL-controlled, study (n = 59) | IV low and high dose |
Primary outcome measures: No. of subjects with PPPASI 50 at wk 16, no. of subjects with AEs Secondary outcome measures: No. of subjects with PPPASI-75 at wk 16, no. of subjects with PPP PGA 0 or 1 |
Recruitment completed (no results posted) | NCT03135548 |
| BI 655130/spesolimab (palmoplantar pustulosis) | A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients with a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis [120] | Phase IIb, multicenter, double-blind, randomized, PL-controlled, dose-finding study (n = 140) | SC different doses |
Primary outcome measure: Percent change in PPPASI from baseline at wk 16 Secondary outcome measures: Change from baseline in PPP Pain VAS score at wk 4 and 16, PPPASI change from baseline, PPPASI-50, PPPASI-75, PPP PGA clear/almost clear, PPP PGA pustules clear/almost clear at wk 16. Percent change in PPPASI from baseline at wk 52 |
Recruiting (no results posted) | NCT04015518 |
| CSL324 (hidradenitis suppurativa; palmoplantar pustulosis) | Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects with Hidradenitis Suppurativa and Palmoplantar Pustulosis | Phase I, multicenter, open-label, 2-regimen, repeat-dose study (n = 40) | IV |
Primary outcome measure: Incidence of treatment-emergent adverse events and adverse events of special interest Secondary outcome measures: Maximum concentration of CSL324 in serum, half-life of CSL324 in serum for last dose administered, presence of anti-CSL324 antibodies in serum |
Recruiting (no results posted) | NCT03972280 |
| KHK4827/brodalumab (palmoplantar pustulosis) | A Study of KHK4827 in Subjects with Palmoplantar Pustulosis | Phase III, PL-controlled, double-blind comparative study (n = 120) | SC 210 mg every 2 wk |
Primary outcome measure: Percent change in PPPASI from baseline at wk 16 Secondary outcome measures: Change from baseline in PPSI total score at wk 16, PPPASI change from baseline, PPPASI-50, PPPASI-75, PPP PGA clear/almost clear at wk 16, change from baseline in DLQI at 16 wk |
Recruiting (no results posted) | NCT04061252 |
| RIST4721/AZD4721 (palmoplantar pustulosis) | A Study to Evaluate RIST4721 in Palmoplantar Pustulosis | Phase IIa, randomized, PL-controlled, double-blind study (n = 35) | PO 300 mg once daily for 28 days |
Primary outcome measures: Relative change in fresh and total pustule count Secondary outcome measures: Absolute change in total and fresh pustule count, portion of subjects achieving ≥ 50% reduction in fresh and total pustule count |
Recruitment completed (no results posted) | NCT03988335 |
AEs adverse events, DLQI Dermatology Life Quality Index, IV intravenous, PASI Psoriasis Area Severity Index, PL placebo, PO oral administration, PPIGA Palmoplantar Pustulosis (Static) Investigator’s Global Assessment score, PPP palmoplantar pustulosis, PPP PGA Palmoplantar Pustulosis Physicians Global Assessment, PPPASI Palmoplantar Pustulosis Area and Severity Index, PPSI Palmoplantar Pustulosis Severity Index, pt(s) patient(s), SC subcutaneous, TBSAI Total Body Surface Area Index, VAS visual analog scale, wk week(s)