Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects

Psoriasis Clinical Trial

Official title:

Multicenter, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL17A/F Nanobody) in Male and Female Subjects With Moderate to Severe Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156466
• Other study ID #: 200574-003
• Secondary ID: 2013-005436-18
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2014
• Last updated: November 9, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: The Central Register of Clinical TrialsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesHungary: Scientific and Medical Research Council Ethics CommitteeCzech Republic: State Institute for Drug ControlCzech Republic: Ethics CommitteeSlovakia: State Institute for Drug ControlSlovak Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F [Anti-IL-17A/F] Nanobody).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic plaque psoriasis for at least 6 months before screening

• Greater than or equal to (>=) 10% of BSA with plaques

• Psoriasis Area and Severity Index (PASI) >=12

• Static Physician's Global Assessment (sPGA) >=3 (where scores range from 0 [clear of disease] to 5 [severe disease]) at the screening and baseline visits

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation

• Currently having a form of non-plaque psoriasis as specified in the protocol

• Drug induced psoriasis

• Biological treatments as specified in the protocol, within 3 months prior to Day 1

• Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1

• Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol

• Use of aspirin as defined in the protocol

• Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1

• Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol

• Other protocol defined exclusion criteria could apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• MSB0010841 (Anti-IL-17A/F Nanobody)
MSB0010841 (Anti-IL-17A/F Nanobody) will be administered at a dose ranging from 30 milligram (mg) to 240 mg as subcutaneous injection every other week for a total duration of 6 weeks.
• Placebo matched to MSB0010841 (Anti-IL-17A/F Nanobody)
Placebo matched to MSB0010841 (Anti-IL-17A/F Nanobody) will be administered as subcutaneous injection every other week for a total duration of 6 weeks.

Locations

Country	Name	City	State
Germany	Please contact the Merck KGaA Communication Center	Darmstadt

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment Emergent Adverse Events (TEAEs)		Baseline up to Day 85	Yes
Primary	Number of Subjects With Local Injection Site Reactions (ISRs)	Number of subjects with local ISRs of swelling, redness, induration, bruising as assessed by the Investigator and severity of pain and itching as assessed by the subject will be reported.	Baseline up to Day 43	Yes
Primary	Percentage of Subjects with Anti-MSB0010841 Antibodies (BAbs)		Baseline up to Day 85	Yes
Primary	Levels of Pre-existing Anti-MSB0010841 Antibody		Baseline	Yes
Primary	MSB0010841 (Anti-IL-17A/F Nanobody) Serum Concentration		Days 1, 15, 29, 43, 50, 63, 73, and 85	No
Primary	Pharmacokinetics Profile post First and Third Dose of MSB0010841 (Anti-IL-17A/F Nanobody): AUC (0-t), AUC (0-tau), AUC (0-inf), Cpre, Cmin, Cmax, Cav, MRT (0-tau), MRT (0-inf), tmax, t1/2, lambda_z, CL/f, Vz/f, PTF, Accumulation Ratio of Cmax, and AUC		Days 1, 29, 43, 50, 63, 73, and 85	No
Primary	Pharmacokinetics Profile Post Second Dose of MSB0010841 (Anti-IL-17A/F Nanobody): Cmax, tmax, Cpre		Day 15	No
Secondary	Percentage of Subjects With 50 or 75% Improvement in Psoriasis Area and Severity Index (PASI) Score Compared to Baseline		Baseline up to Day 85	No
Secondary	Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43		Baseline, Day 43	No
Secondary	Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at least 2 Level Reduction From Baseline		Baseline up to Day 85	No
Secondary	Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Days 8, 15, 22, 29, 36, 43, 50, and 85		Baseline, Days 8, 15, 22, 29, 36, 43, 50, and 85	No
Secondary	Percentage of Subjects with Exacerbation of Psoriasis	Psoriasis exacerbation is defined as either 1) A worsening of 25% over the baseline value of the PASI score (PASI score at any visit >=125% of baseline PASI) or 2) A reported adverse event (AE) suggesting disease worsening that is more inflammatory in nature compared to baseline and occurs either within pre-existing plaques, at previously uninvolved sites, or as new morphologies of disease compared to baseline.	Baseline up to Day 85	No