| Study name |
Expectation‐induced enhancement of pain, itch and quality of life in psoriasis patients |
| Methods |
RCT, active‐controlled study
Date of study: November 2020
Location: Sweden |
| Participants |
Randomised: 120 participants
Inclusion criteria
Diagnosis of moderate‐to‐severe chronic plaque psoriasis for at least 6 months Psoriasis Area and Severity Index > 12 and body surface area affected by plaque psoriasis ≥ 10% Patient is a candidate for systemic therapy (this is defined as a patient having moderate‐to‐severe chronic plaque psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy) Women must not be pregnant and, if of childbearing potential, must have a negative serum pregnancy test before entering the study Women of childbearing potential must agree to use a highly effective method of contraception throughout the therapy
Exclusion criteria
Age < 18 years Forms of psoriasis other than chronic plaque (e.g. pustular, erythrodermic, guttate, or drug‐induced) psoriasis Existing contraindication to therapy with secukinumab according to the summary of product characteristics like history of hypersensitivity to secukinumab or its excipients or to drugs of similar chemical classes or clinically relevant (chronic or acute) infections, for example, untreated (latent) tuberculosis or HIV infection Significant medical problems, which in the opinion of the investigator significantly immunocompromise the subject and/or place the subject at unacceptable risk for receiving therapy with secukinumab History of, respectively active, inflammatory bowel disease Administration of live vaccines < 6 weeks before first injection of secukinumab Any medical or psychiatric condition which, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol Previous exposure to secukinumab Ongoing use of systemic antipsoriatic treatments (concomitant topical treatment is allowed) History or evidence of ongoing alcohol or drug abuse, within the last 6 months before start of the study Subject is lacking capacity to consent
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| Interventions |
Group 1 pharmacological control: secukinumab (as in clinical routine consisting of 2 subcutaneous injections with 150 mg) for 5 weeks (weeks 0 to 4), followed by 2 additional injections 4 (week 8) and 8 (week 12) weeks later, n = 40
Expectation‐LOW group 2: secukinumab 75 mg as 1 injection and 1 injection with NaCl, n = 40
Expectation‐HIGH group 3: secukinumab 75 mg as one injection and an additional positive verbal instruction presented in a standardised manner by the main study physician to strengthen their expectation towards the benefits of the treatment. The salience of this verbal instruction will be reinforced by combining each injection with the ingestion of a newly tasting beverage together with detailed information about the potential beneficial effects of this combination, n = 40 |
| Outcomes |
At 16 weeks
Primary outcomes
Secondary outcomes
Lesion severity Immunological markers
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| Starting date |
Date of study: November 2020‐2023 |
| Contact information |
Dr. Wiebke Sondermann; wiebke.sondermann@uk‐essen.de |
| Notes |
Funding: "Gefördert durch die Deutsche Forschungsgemeinschaft (DFG)— Projektnummer 422744262—TRR 289—Funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation)—Project‐ID 422744262—TRR 289)."
Declarations of interest: "WS reports grants from medi Bayreuth, personal fees from Janssen, grants and personal fees from Novartis, personal fees from Lilly UCB, Almirall, LEO Pharma and Sanofi Genzyme, outside the submitted work. The other authors declare that they have no competing interests."
Last checked in October 2022 |
