A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Psoriatic Arthritis Clinical Trial

Official title:

A 24-Week Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety of Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis or Active Psoriatic Arthritis in India

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05855967
• Other study ID #: 18528
• Secondary ID: I1F-IN-RHCZ
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 27, 2023
• Est. completion date: September 20, 2024

Study information

• Verified date: February 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to investigate the safety and tolerability of ixekizumab in participants in India with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: September 20, 2024
• Est. primary completion date: July 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All participants:

• Male or nonpregnant, nonbreastfeeding female participants.

For PsO Participants:

• Present with chronic PsO based on a confirmed diagnosis of chronic PsO vulgaris for at least 6 months prior to baseline

• Have =10% Body Surface Area (BSA) of psoriasis at screening (Visit 1) and baseline

• Have both an sPGA score of =3 and PASI score =12 at screening and baseline

For PsA Participants

• Have a diagnosis of active PsA for at least 6 months (based on a detailed medical history provided by the patient, and a physical exam by the Study Investigator, and/or other evidence such as that provided by joint x-rays, that establishes a history consistent with a diagnosis of active PsA of at least 6 months' duration) and currently meet the Classification for PsA (CASPAR) criteria.

• Have active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints, as determined by the Tender and Swollen Joint Count Assessment Form at screening and baseline.

• Presence of active PsO or a documented history of psoriasis.

Exclusion Criteria:

• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.

• Have a history of drug-induced PsO.

• Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study.

• Had any major surgery within 8 weeks prior to baseline (Week 0; Visit 2), or will require such during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant

• Have diagnosis or history of malignant disease within the 5 years prior to baseline

• Have any other active or recent infection within 4 weeks of baseline

For PsO Participants:

• Have received systemic non-biologic PsO therapy (within 4 weeks prior to baseline)

• Have pustular, erythrodermic, and/or guttate forms of PsO

• Had a clinically significant flare of PsO during the 12 weeks prior to baseline (Week 0).

• Have allergy to rubber or latex.

For PsA Participants:

• Have used conventional synthetic disease-modifying antirheumatic drug (csDMARDs) other than methotrexate (MTX), leflunomide, sulfasalazine, or cyclosporine in the 8 weeks prior to baseline

• Have received treatment with interleukin (IL)17 or IL-12/23 targeted Mab therapy

• Are currently receiving treatment with any biologic or small molecule therapy for PsA or PsO, including investigational therapies (such as, but not limited to, a tumor necrosis factor inhibitor (TNFi), IL-1 receptor antagonists, IL-6 inhibitor, anti-IL12/23p40, T cell or B cell targeted therapies, phosphodiesterase (PDE) 4 inhibitors, or Janus Kinase (JAK) inhibitors), or have received denosumab.

• Have had surgical treatment of a joint within 8 weeks prior to baseline or will require such up to Week 24.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis

Intervention

Drug:
• Ixekizumab
Administered SC

Locations

Country	Name	City	State
India	Amber Clinic	Ahmedabad	Gujarat
India	B. J. Medical College & Civil Hospital	Ahmedabad	Gujarat
India	GMERS Medical College & Hospital	Ahmedabad	Gujarat
India	V.S. General Hospital	Ahmedabad	Gujarat
India	Postgraduate Institute of Medical Education & Research	Chandigarh	Punjab
India	Medical College & Hospital	Kolkata	West Bengal
India	Wizderm Specialty Skin And Hair Clinic	Kolkata	West Bengal
India	Father Muller Medical College Hospital	Mangalore	Karnataka
India	Dr. D. Y. Patil Medical College & Hospital	Navi Mumbai	Maharashtra
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
India	Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)	Pune	Maharashtra
India	All India Institute of Medical Sciences	Raipur	Chhattisgarh
India	Tristar Hospital	Surat	Gujarat
India	King George Hospital	Vizag	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Plaque Psoriasis and with Psoriatic Arthritis Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs)		Baseline to Week 24
Secondary	Percentage of Participants Who Achieve 75% Improvement from Baseline in the Psoriasis Area and Severity Index 75 (PASI 75)		Week 12
Secondary	Percentage of Participants with a Static Physician Global Assessment (sPGA) Score of 0 or 1 (0,1)		Week 12
Secondary	Percentage of PsA Participants Who Achieve 20% Improvement from Baseline in American College of Rheumatology 20 (ACR20)		Week 24