NCT04944862 is a Phase 1 clinical trial of CDX-0159 in Prurigo Nodularis, sponsored by Celldex Therapeutics.

Who is sponsoring NCT04944862?

NCT04944862 is sponsored by Celldex Therapeutics.

What drugs are being tested in NCT04944862?

Interventions in NCT04944862: CDX-0159, Normal saline.

What condition does NCT04944862 study?

NCT04944862 studies Prurigo Nodularis.

Is NCT04944862 still recruiting?

NCT04944862 is currently completed. Last updated 14 August 2023.

Last reviewed 2023-08-14 · How we verify

NCT04944862

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

A Study of CDX-0159 in Patients With Prurigo Nodularis

Completed Phase 1 Last updated 14 August 2023

What this trial tests

Phase 1 trial testing CDX-0159 in Prurigo Nodularis in 24 participants. Completed in 31 July 2023.

Timeline

8 November 2021

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	Celldex Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	8 November 2021
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	17 locations across United States, Germany, Poland

Drugs / interventions tested

CDX-0159 — full drug profile →
Normal saline

Conditions studied

Prurigo Nodularis — all drugs for Prurigo Nodularis →

Sponsor

Celldex Therapeutics — full company profile →

Who can join

Adults 18 to 75, any sex, with Prurigo Nodularis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

Publications & conference data

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

Prurigo nodularis: new insights into pathogenesis and novel therapeutics.
Liao V, Cornman HL, Ma E, Kwatra SG. · · 2024 · cited 38× · PMID 38345154 · DOI 10.1093/bjd/ljae052
Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments.
Müller S, Zeidler C, Ständer S. · · 2024 · cited 38× · PMID 37717255 · DOI 10.1007/s40257-023-00818-z
Molecular mechanisms of pruritus in prurigo nodularis.
Shao Y, Wang D, Zhu Y, Xiao Z, et al · · 2023 · cited 29× · PMID 38077377 · DOI 10.3389/fimmu.2023.1301817
Chronic Nodular Prurigo: An Update on the Pathogenesis and Treatment.
Wong LS, Yen YT. · · 2022 · cited 22× · PMID 36293248 · DOI 10.3390/ijms232012390
Prurigo Nodularis: Pathogenesis and the Horizon of Potential Therapeutics.
Yook HJ, Lee JH. · · 2024 · cited 18× · PMID 38791201 · DOI 10.3390/ijms25105164
New and Emerging Biologics and Jak Inhibitors for the Treatment of Prurigo Nodularis: A Narrative Review.
Bianco M, D'Oria F, Falcidia C, Foggi G, et al · · 2025 · cited 5× · PMID 40282922 · DOI 10.3390/medicina61040631

Verify or expand the search:

Other trials of CDX-0159

Trials testing the same drug.

NCT05031624 — A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects · Phase 1 · completed
NCT04548869 — A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urtic · Phase 1 · completed
NCT04538794 — A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria · Phase 1 · completed
NCT04146129 — A Phase 1 Study of CDX-0159 · Phase 1 · completed

Other recruiting trials for Prurigo Nodularis

Currently open trials in the same condition.

NCT06988618 — Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults · recruiting
NCT06994520 — Efficacy of Topical Cannabidiol for Eczema · Phase 2 · active not recruiting
NCT06516965 — A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2) · Phase 3 · active not recruiting
NCT06516952 — A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1) · Phase 3 · recruiting
NCT06554509 — Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis · Phase 2, PHASE3 · recruiting

Other Celldex Therapeutics trials

Trials by the same sponsor.

NCT05774184 — A Study of CDX-0159 in Patients With Eosinophilic Esophagitis · Phase 2 · completed
NCT05788484 — A Study of CDX-585 in Patients With Advanced Malignancies · Phase 1 · completed
NCT05405660 — A Study of CDX-0159 in Patients With Chronic Inducible Urticaria · Phase 2 · completed
NCT05368285 — A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria · Phase 2 · completed
NCT05031624 — A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects · Phase 1 · 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 NCT04944862 (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 Celldex Therapeutics
Last refreshed: 14 August 2023

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/NCT04944862.

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