NCT05855967CompletedPhase 4
A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 250 (actual)
- First submitted
- 4 May 2023
- Start date
- 27 Jun 2023
- Primary completion date
- 8 Aug 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT05855967
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 250
- From 27 Jun 2023 to the primary completion date, 8 Aug 2024
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.
- 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 received systemic non-biologic PsO therapy (within 4 weeks prior to baseline)
- Had a clinically significant flare of PsO during the 12 weeks prior to baseline (Week 0).
- 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.
Other illness
- 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.
- 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 allergy to rubber or latex.
- For PsA Participants:
Other
- Have pustular, erythrodermic, and/or guttate forms of PsO
Who the study is looking for
- 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 static Physician's Global Assessment (sPGA) score of ≥3 and Psoriasis Area and Severity Index (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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| B. J. Medical College & Civil Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| V.S. General Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| GMERS Medical College & Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Amber Clinic Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Postgraduate Institute of Medical Education & Research Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
| Wizderm Specialty Skin And Hair Clinic Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Medical College & Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Father Muller Medical College Hospital Coordinator of this site? Confirm its status | Mangalore | India | Unknown status |
| Dr. D. Y. Patil Medical College & Hospital Coordinator of this site? Confirm its status | Navi Mumbai | India | Unknown status |
| Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.) Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Grant Medical Foundation Ruby Hall Clinic Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Raipur | India | Unknown status |
| Tristar Hospital Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| King George Hospital Coordinator of this site? Confirm its status | Vizag | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.