NCT02345928

A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis

Completed Phase 1 Last updated 16 November 2020

What this trial tests

Phase 1 trial testing Part 1: CNTO 7160 in Asthma in 108 participants. Completed in 16 March 2017.

Timeline

5 August 2014

Primary endpoint
16 March 2017

16 March 2017

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Enrollment	108
Start date	5 August 2014
Primary completion	16 March 2017
Estimated completion	16 March 2017
Sites	7 locations across Belgium, Germany

Drugs / interventions tested

• Part 1: CNTO 7160 — full drug profile →
• Part 2 (Asthma): CNTO 7160 — full drug profile →
• Part 2 (Atopic Dermatitis): CNTO 7160 — full drug profile →
• Part 1 and Part 2: Placebo — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →
• Atopic Dermatitis — all drugs for Atopic Dermatitis →
• Healthy — all drugs for Healthy →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 55, any sex, with Asthma or Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis.

Publications & conference data

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

1. T cell pathology in skin inflammation.
   Sabat R, Wolk K, Loyal L, Döcke WD, et al · · 2019 · cited 134× · PMID 31028434 · DOI 10.1007/s00281-019-00742-7
2. The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis.
   Nnane I, Frederick B, Yao Z, Raible D, et al · · 2020 · cited 36× · PMID 32415720 · DOI 10.1111/bcp.14361
3. IL33 and Mast Cells-The Key Regulators of Immune Responses in Gastrointestinal Cancers?
   Eissmann MF, Buchert M, Ernst M. · · 2020 · cited 31× · PMID 32719677 · DOI 10.3389/fimmu.2020.01389
4. IL-33/ST2 axis in diverse diseases: regulatory mechanisms and therapeutic potential.
   Sheng F, Li M, Yu JM, Yang SY, et al · · 2025 · cited 16× · PMID 39925809 · DOI 10.3389/fimmu.2025.1533335
5. Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives.
   Alska E, Łaszczych D, Napiórkowska-Baran K, Szymczak B, et al · · 2025 · cited 13× · PMID 40004611 · DOI 10.3390/jcm14041079
6. Blockade of IL-1 family cytokines in the treatment of rheumatoid arthritis.
   Wang K, Luo H, Liu L, Gao H, et al · · 2025 · cited 10× · PMID 40520203 · DOI 10.3389/fphar.2025.1577628
7. Safety, tolerability, and pharmacokinetics of a single ascending subcutaneous dose of GSK3772847 in healthy participants.
   Pefani E, Stone S, Zhu CQ, Nunn C, et al · · 2023 · cited 4× · PMID 36846967 · DOI 10.1002/prp2.1054
8. A model-based approach using GSK3772847, an anti-interleukin-33 receptor monoclonal antibody, as a showcase to predict SC administration PK and free target dynamics based on PK and total target measurements after IV administration.
   Berkhout J, Fairman D, van Noort M, van Steeg TJ. · · 2025 · cited 1× · PMID 39258338 · DOI 10.1002/psp4.13234