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New injection shows promise for relieving intense itching

NCT ID NCT06424470

Symptom relief Sponsor: Keymed Biosciences Co.Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether Stapokibart injection can reduce severe itching and skin bumps in adults with prurigo nodularis. About 200 participants will receive either the drug or a placebo for 24 weeks. The main goal is to see if itching improves by at least 4 points on a 0-10 scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stapokibart injection
What this could lead to
If successful, this could provide a new treatment option to reduce severe itching and clear skin nodules in people with prurigo nodularis.
What could go wrong
This is a single Phase 3 trial with 200 participants. Results may not apply to everyone, and side effects or lack of benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

200 people

The number who actually took part.

Started

Jun 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form. * 18 ≤ Age ≤ 75 years old. * Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy. Exclusion Criteria: * With drug-induced prurigo nodularis. * With clinically significant diseases. * With severe liver and kidney function damage at the screening. * With malignant tumors within the first 5 years before the screening. * Plan to undergo major surgical procedures during this study.

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Conditions

The condition(s) this trial relates to.

prurigo nodularis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prurigo nodularis

Contacts and locations

Locations

  • The First Hospital of China Medical University

    Shenyang, Liaoning, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.