Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05411016 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 125 participants (planned 157)
    • Study completion date changed from estimate of Dec 2025 to Oct 27, 2025
    • Eligibility criteria expanded, about 16 words
    • Site details revised at 2 of 23 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2024 to Dec 10, 2024
    • Study sites revised (23)
    v4
  3. Enrollment target: 116 to 157
    • Study sites: 1 to 23
    • Study completion date: Mar 2025 to Dec 2025
    • Start date: Jul 19, 2022 to Aug 3, 2022
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Sep 2023 to Dec 2024
    • Study completion date: Sep 2024 to Mar 2025
    • Start date changed from estimate of Jul 11, 2022 to Jul 19, 2022
    • Site details revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males. Part 2 : To evaluate the safety and tolerability of repeated IV or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).
Trial Details
NCT Number NCT05411016
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions
(from sponsor)		 Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
Related terms Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov