MedPath

Tildrakizumab

Generic Name
Tildrakizumab
Brand Names
Ilumya, Ilumetri
Drug Type
Biotech
CAS Number
1326244-10-3
Unique Ingredient Identifier
DEW6X41BEK
Background

Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis .

The Food and Drug Administration (FDA) approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in March 2018. The approved recommended dosage of ILUMYA is a subcutaneous injection of 100 mg at Weeks 0, 4, and every 12 weeks thereafter .

A study was performed on the pharmacokinetics of this drug on various ethnicities. The pharmacokinetics of tildrakizumab were similar in Japanese, Caucasian, and Chinese subjects .

Indication

Moderate-severe plaque psoriasis , .

Associated Conditions
Moderate to Severe Plaque Psoriasis

ILUMYA in Combination With HALOG Ointment 0.1% for Plaque Psoriasis.

Phase 4
Recruiting
Conditions
Psoriasis
Interventions
First Posted Date
2020-04-15
Last Posted Date
2020-04-15
Lead Sponsor
Psoriasis Treatment Center of Central New Jersey
Target Recruit Count
25
Registration Number
NCT04347473
Locations
🇺🇸

Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey, United States

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

First Posted Date
2020-04-09
Last Posted Date
2024-01-19
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
244
Registration Number
NCT04340076
Locations
🇳🇱

Amphia Hospital, Breda, Netherlands

🇳🇱

Radboudumc, Nijmegen, Netherlands

🇳🇱

Máxima Medisch Centrum, Veldhoven, Netherlands

and more 16 locations

MIcrovascular dysfuNction In Moderate-severe Psoriasis

Phase 4
Active, not recruiting
Conditions
Psoriasis
Cardiovascular Disease
Interventions
First Posted Date
2020-02-17
Last Posted Date
2025-05-13
Lead Sponsor
Marcelo F. Di Carli, MD, FACC
Target Recruit Count
36
Registration Number
NCT04271540
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy

Phase 4
Completed
Conditions
Plaque Psoriasis
Interventions
Drug: Dimethyl fumarate (DMF) standard scheme
Drug: Dimethyl fumarate (DMF) simplified scheme
First Posted Date
2020-02-11
Last Posted Date
2022-05-27
Lead Sponsor
Almirall, S.A.
Target Recruit Count
190
Registration Number
NCT04263610
Locations
🇩🇪

Investigator Site 3, Augsburg, Germany

🇬🇧

Investigator Site 2, London, United Kingdom

🇬🇧

Investigator Site 1, Bristol, United Kingdom

Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)

Phase 4
Completed
Conditions
Plaque Psoriasis
Interventions
First Posted Date
2020-01-18
Last Posted Date
2023-03-03
Lead Sponsor
Almirall, S.A.
Target Recruit Count
178
Registration Number
NCT04229836
Locations
🇪🇸

Investigator Site 8, Madrid, Spain

🇪🇸

Investigator Site 9, Madrid, Spain

🇮🇹

Investigator Site 10, Novara, Italy

and more 19 locations

Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Completed
Conditions
Plaque Psoriasis
Interventions
First Posted Date
2019-12-18
Last Posted Date
2024-07-08
Lead Sponsor
Almirall, S.A.
Target Recruit Count
331
Registration Number
NCT04203693
Locations
🇳🇱

Investigational site 1, Breda, Netherlands

🇮🇹

Investigational site 5, Roma, Italy

🇩🇪

Investigational site 13, Berlin, Germany

and more 11 locations

Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease

Phase 2
Completed
Conditions
Hematologic Malignancies
Interventions
First Posted Date
2019-10-02
Last Posted Date
2024-06-24
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
51
Registration Number
NCT04112810
Locations
🇺🇸

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Phase 2
Recruiting
Conditions
Moderate-to-severe Chronic Plaque Psoriasis
Interventions
First Posted Date
2019-06-25
Last Posted Date
2025-02-26
Lead Sponsor
Sun Pharmaceutical Industries Limited
Target Recruit Count
130
Registration Number
NCT03997786
Locations
🇵🇱

Site 57, Bialystok, Poland

🇵🇱

Site 55, Gdańsk, Poland

🇵🇱

Site 51, Katowice, Poland

and more 47 locations

Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

First Posted Date
2019-06-20
Last Posted Date
2025-04-06
Lead Sponsor
Sun Pharmaceutical Industries Limited
Target Recruit Count
200
Registration Number
NCT03992729
Locations
🇺🇸

Christina Chambers, San Diego, California, United States

Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

Phase 3
Active, not recruiting
Conditions
Chronic Plaque Psoriasis
Moderate to Severe Nail Psoriasis
Interventions
Drug: Placebo
First Posted Date
2019-04-01
Last Posted Date
2024-12-20
Lead Sponsor
Sun Pharmaceutical Industries Limited
Target Recruit Count
99
Registration Number
NCT03897075
Locations
🇺🇸

California Dermatology & CRI (Site 18), Encinitas, California, United States

🇺🇸

First OC Dermatology (Site 07), Fountain Valley, California, United States

🇺🇸

Dermatology Research Associates (Site 09), Los Angeles, California, United States

and more 14 locations
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