Phase 1 Lupus Trial, Recruiting NCT07011043 Sponsor: Climb Bio, Inc. Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT07011043
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 65 years old at the time of signing consent
  • You have been diagnosed with Systemic Lupus Erythematosus (SLE or Lupus) according to specific recognised medical guidelines (2019 EULAR/ACR criteria)
  • Your lupus is currently active and has been confirmed through blood tests, with a disease activity score of 8 or higher on a standard measurement scale called SLEDAI 2K
  • Your lupus has not responded well enough to at least 2 previous treatments, including at least one medication taken by mouth or a biologic therapy (a more advanced type of medication)

Who may not be able to join:

  • You currently have lupus that is affecting your brain or mental health (sometimes called neuropsychiatric lupus)
  • You have a history of certain other immune system or inflammatory conditions, such as rheumatoid arthritis, scleroderma, myositis, vasculitis, or inflammatory bowel disease — though people with stable Sjögren's syndrome, asthma, or autoimmune thyroid disease may still be considered (confirm with trial site)
  • You currently have an active infection anywhere in your body, or you have a history of long-term, repeated, hidden, or recent serious infections

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, Climb Bio, Inc.

Phone: +1 866 857 2596

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Climb Bio, Inc.
Registry
ClinicalTrials.gov
Start date
10 July 2025
Est. completion
1 April 2027

Where this trial is recruiting

🇧🇬 Bulgaria 🇬🇪 Georgia 🇬🇷 Greece Puerto Rico 🇷🇴 Romania 🇪🇸 Spain 🇺🇦 Ukraine 🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events (TEAEs); Incidence of Clinical Laboratory Abnormalities; Change from Baseline in Systolic Blood Pressure; Change from Baseline in Diastolic Blood Pressure; Change from Baseline in Heart Rate; Change from Baseline in Respiratory Rate; Change from Baseline in Body Temperature; Change from Baseline in PR Interval; Change from Baseline in QRS Duration; Change from Baseline in QT Interval; Change from Baseline in QTc Interval

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov