NCT03161288 is a Phase 1 clinical trial of KY1005 in Immune System Diseases, sponsored by Kymab Limited.

Who is sponsoring NCT03161288?

NCT03161288 is sponsored by Kymab Limited.

What drugs are being tested in NCT03161288?

Interventions in NCT03161288: KY1005, Placebo.

What condition does NCT03161288 study?

NCT03161288 studies Immune System Diseases.

Is NCT03161288 still recruiting?

NCT03161288 is currently completed. Last updated 29 August 2019.

Last reviewed 2019-08-29 · How we verify

NCT03161288

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of KY1005 in Healthy Volunteers

Completed Phase 1 Last updated 29 August 2019

What this trial tests

Phase 1 trial testing KY1005 in Immune System Diseases in 64 participants. Completed in 30 March 2018.

Timeline

29 May 2017

Primary endpoint
30 March 2018

30 March 2018

Quick facts

Lead sponsor	Kymab Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	64
Start date	29 May 2017
Primary completion	30 March 2018
Estimated completion	30 March 2018
Sites	1 location across Netherlands

Drugs / interventions tested

KY1005 — full drug profile →
Placebo

Conditions studied

Immune System Diseases — all drugs for Immune System Diseases →

Sponsor

Kymab Limited — full company profile →

Who can join

Adults 18 to 45, male only, with Immune System Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study to evaluate the safety and tolerability of KY1005 in healthy volunteers.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Combined OX40L and mTOR blockade controls effector T cell activation while preserving T<sub>reg</sub> reconstitution after transplant.
Tkachev V, Furlan SN, Watkins B, Hunt DJ, et al · · 2017 · cited 72× · PMID 28931653 · DOI 10.1126/scitranslmed.aan3085
OX40-OX40L Inhibition for the Treatment of Atopic Dermatitis-Focus on Rocatinlimab and Amlitelimab.
Lé AM, Torres T. · · 2022 · cited 60× · PMID 36559247 · DOI 10.3390/pharmaceutics14122753
TNF superfamily control of tissue remodeling and fibrosis.
Steele H, Cheng J, Willicut A, Dell G, et al · · 2023 · cited 50× · PMID 37465675 · DOI 10.3389/fimmu.2023.1219907
OX40L Inhibition Suppresses KLH-driven Immune Responses in Healthy Volunteers: A Randomized Controlled Trial Demonstrating Proof-of-Pharmacology for KY1005.
Saghari M, Gal P, Gilbert S, Yateman M, et al · · 2022 · cited 40× · PMID 35092305 · DOI 10.1002/cpt.2539
Emerging Biologic Therapies for the Treatment of Atopic Dermatitis.
Alvarenga JM, Bieber T, Torres T. · · 2024 · cited 20× · PMID 39365406 · DOI 10.1007/s40265-024-02095-4
T cell co-stimulatory and co-inhibitory pathways in atopic dermatitis.
Zheng C, Shi Y, Zou Y. · · 2023 · cited 11× · PMID 36993982 · DOI 10.3389/fimmu.2023.1081999
The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis.
Oliveira Dos Santos D, Mohamed A, Mohamed A, Alvarenga JM, et al · · 2026 · PMID 41535648 · DOI 10.1007/s40259-025-00762-w
Population Pharmacokinetic and Pharmacodynamic Modeling for the Prediction of the Extended Amlitelimab Phase 3 Dosing Regimen in Atopic Dermatitis.
Tiraboschi G, Papp K, Bieber T, Weidinger S, et al · · 2025 · PMID 41035282 · DOI 10.1002/psp4.70121

Verify or expand the search:

Other trials of KY1005

Trials testing the same drug.

NCT04449939 — A Study of Subcutaneous KY1005 in Healthy Volunteers · Phase 1 · completed
NCT03754309 — A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis · Phase 2 · completed

Other recruiting trials for Immune System Diseases

Currently open trials in the same condition.

NCT06575426 — A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes M · Phase 1, PHASE2 · recruiting
NCT06353087 — Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry) · recruiting
NCT06271252 — A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study · Phase 1 · recruiting
NCT06353035 — Biodiversity Interventions for Well-Being · NA · active not recruiting
NCT04656873 — Immuno-Oncology Database and Bioregistry · active not recruiting

Other Kymab Limited trials

Trials by the same sponsor.

NCT05131477 — Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study · Phase 2 · completed
NCT04449939 — A Study of Subcutaneous KY1005 in Healthy Volunteers · Phase 1 · completed
NCT03829501 — A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Co · Phase 1, PHASE2 · terminated
NCT03754309 — A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03161288 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kymab Limited
Last refreshed: 29 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03161288.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing