APRICOT - Anakinra for pustular psoriasis

Phase 4

• Conditions: Palmo-plantar pustulosis; Skin and Connective Tissue Diseases; Palmo-plantar pustulosis (PPP)

• Registration Number: ISRCTN13127147
• Lead Sponsor: Guy's And St Thomas' NHS Foundation Trust

Brief Summary

2018 protocol in https://pubmed.ncbi.nlm.nih.gov/30157880/ (added 05/08/2020) 2020 statistical analysis plan in https://www.ncbi.nlm.nih.gov/pubmed/32041649 (added 12/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-01
• Last Update Posted: 17 August 2020
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Adults (18 years and over) with diagnosis of Palmo-Plantar Pustulosis (PPP) made by a trained dermatologist with disease of sufficient impact and severity to require systemic therapy
2. Disease duration of >6 months, not responding to an adequate trial of topical therapy including very potent corticosteroids
3. Evidence of active pustulation on palms and /or soles to ensure sufficient baseline disease activity to detect efficacy
4. At least moderate disease on the PPP Investigator’s Global Assessment (PPP-IGA)
5. Women of child bearing potential who are on adequate contraception, who are not pregnant or breast feeding
6. Who have given written, informed consent to participate

Exclusion Criteria

1. Previous treatment with anakinra or other IL-1 antagonists
2. A history of recurrent bacterial, fungal or viral infections
3. Evidence of active infection or latent TB or who are HIV, Hepatitis B or C sero-positive
4. A history of malignancy of any organ system (other than treated, localised non melanoma skin cancer), treated or untreated, within the past 5 years
5. Use of therapies with potential or known efficacy in psoriasis during or within the following specified timeframe before treatment initiation (week 0, visit 2):
5.1. very potent topical corticosteroids within 2 weeks
5.2. topical treatment that is likely to impact signs and symptoms of psoriasis (e.g. corticosteroids, vitamin D analogues, calcineurin inhibitors, retinoids, keratolytics, tar, urea within 2 weeks
5.3. methotrexate, ciclosporin, acitretin, alitretinoin within 4 weeks
5.4. phototherapy or PUVA within 3 months
5.5. etanercept or adalimumab within 4 weeks
5.6. infliximab or ustekinumab or secukinumab within 3 months
5.7. other TNF antagonists within 3 months
5.8. other immunosuppressive or immunomodulatory therapy within 30 days or 5 half lives prior to treatment initiation, whichever is longer
5.9. any other investigational drugs within 30 days (or 3 months for investigational monoclonal antibodies) or 5 half-lives prior to treatment initiation, whichever is longer
6. With moderate renal impairment [CrCl <50ml/min ]
7. With neutropenia (<1.5x109/L)
8. With known moderate hepatic disease and/or raised hepatic transaminases (ALT/AST) > 2 x ULN at baseline. Patients who fail this screening criterion may still be considered following review by a hepatologist and confirmed expert opinion that study entry is clinically appropriate.
9. Live vaccinations within 3 months prior to the start of study medication, during the trial, and up to 3 months following the last dose
10. Women who are pregnant, breast feeding or of child bearing age not on adequate contraception or men planning conception
11. Poorly controlled diabetes mellitus, cardiovascular disease , asthma, concomitant therapy that may interact with anakinra (for example phenytoin or warfarin) or any condition where, in the opinion of the investigator, anakinra would present risk to the patient
12. Latex allergy (inner needle cover of pre-filled syringe contains natural rubber)
13. Unable to given written, informed consent.
14. Unable to comply with the study visit schedule

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease severity as measured by fresh pustule count (i.e. number of macroscopically visible, sterile, white/yellow pustules present on the palms and soles) and/or palmoplantar pustulosis psoriasis area severity index (PP-PASI) score at baseline, 2, 4, 6 and 8 weeks.