Comparing Anakinra versus placebo in the treatment of pustular psoriasis

Phase 1

• Conditions: Acral Pustular Psoriasis, specifically but not limited to Palmo-Plantar Pustulosis will be the target population for therapeutic intervention with Anakinra in this study.; MedDRA version: 20.0Level: PTClassification code 10037575Term: Pustular psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-003600-23-GB
• Lead Sponsor: Guy's and St Thomas NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-28
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Inclusion criteria for the for the double-blind treatment stage, placebo controlled study.
i. 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
ii. Disease duration of >6 months, not responding to an adequate trial of topical therapy including very potent corticosteroids
iii. Evidence of active pustulation on palms and /or soles to ensure sufficient baseline disease activity to detect efficacy
iv. At least moderate disease on the PPP Investigator’s Global Assessment (PPP-IGA)
v. Women of child bearing potential who are on adequate contraception (see Appendix A , contraception guidelines), who are not pregnant or not breast feeding
vi. Who have given written, informed consent to participate

Inclusion Criteria for the Open Label Extension
i. Participation in the double-blind placebo controlled study.
ii. Completion past Visit 4 (Week 8) of the double-blind placebo controlled study.
iii. Women of child bearing potential who are on adequate contraception (see Appendix A), contraception guidelines), who are not pregnant or not breast feeding
iv. Who have given written, informed consent to participate

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

Double-blind stage
i. Previous treatment with anakinra or other IL-1 antagonists
ii. A history of recurrent bacterial, fungal or viral infections which, in the opinion of the principal investigator, present a risk to the patient
iii. Evidence of active infection or latent TB or who are HIV, Hepatitis B or C sero-positive
iv. A history of malignancy of any organ system (other than treated, localised non melanoma skin cancer), treated or untreated, within the past 5 years
v. Use of therapies with potential or known efficacy in psoriasis during or within the following specified timeframe before treatment initiation (week 0, visit 2):
a. very potent topical corticosteroids within 2 weeks b. 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 c. methotrexate, ciclosporin, acitretin, alitretinoin within 4 weeks d. phototherapy or PUVA within 4 weeks e. etanercept or adalimumab within 4 weeks f. infliximab or ustekinumab or secukinumab within 3 months g. other TNF antagonists within 3 months h. other immunosuppressive or immunomodulatory therapy within 30 days or 5 half lives prior to treatment initiation, whichever is longer
i. 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
vi. With moderate renal impairment[CrCl<50ml/min]
vii. With neutropenia(<1.5x109/L)
viii. With thrombocytopenia(<150x109/L)
ix. With known moderate hepatic disease &/or raised hepatic transaminases (ALT/AST) >2xULN at baseline. Patients who fail this criterion may still be considered following review by a hepatologist&confirmed expert opinion that study entry is clinically appropriate.
x. Live vaccinations within 3 months prior to the start of study medication, during the trial, & up to 3 months following the last dose
xi. Women who are pregnant, breastfeeding or of child bearing age not on adequate contraception or men planning conception
xii. Poorly controlled diabetes mellitus, cardiovascular disease, asthma, concomitant therapy that may interact with anakinra(eg phenytoin or warfarin)or any condition where, in the opinion of the investigator, anakinra would present risk to the patient.
xiii. Unable to given written, informed consent.
xiv. Unable to comply with the study visit schedule
xv.Diagnosis(or historic diagnosis)of either childhood or adult onset Still’s disease.
Open Label Extension
i. A history of recurrent bacterial, fungal or viral infections which, in the opinion of the principal investigator, present a risk to the patient
ii.Evidence of active infection or latent TB or who are HIV, Hepatitis B or C sero-positive(only required for patients who are beyond Visit 5 the double-blind treatment stage, placebo controlled study).
iii.A history of malignancy of any organ system(other than treated, localised non-melanoma skin cancer),treated or untreated, within the past 5 years
iv.Use of therapies with potential or known efficacy in psoriasis during or within the following specified timeframe before treatment initiation (Visit OLE 1):
a. methotrexate, ciclosporin, acitretin, alitretinoin within 4 weeks b. phototherapy or PUVA within 4 weeks c. etanercept or adalimumab within 4 weeks d. infliximab or ustekinumab or secukinumab within 3 months e. other TNF antagonists within 3 months f. other immunosuppres

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified