## Protocol Section
### Identification Module
**NCT ID:** NCT06419205

**Brief Title:** A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G

**Official Title:** A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With IgAN, LN, or C3G

#### Organization Study ID Info
**ID:** ADX-097-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Q32 Bio Inc.
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Q32 Bio Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)

### Conditions Module

**Conditions:**

- IgA Nephropathy

- Lupus Nephritis (LN)

- C3 (Complement Component 3) Glomerulopathy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subcutaneous Placebo Injection

**Intervention Names:**

- Drug: ADX-097

**Label:** Open Label

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Open Label

**Description:** Open Label

**Name:** ADX-097

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Incidence of adverse events (AEs) to evaluate the safety of ADX-097 when administered to participants with IgAN, LN, or C3G

**Measure:** Incidence of adverse events (AEs) to evaluate the safety of ADX-097

**Time Frame:** 42 weeks

#### Secondary Outcomes

**Description:** To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G

**Measure:** Change from baseline in urine protein-to-creatinine ratio (uPCR)

**Time Frame:** 26 weeks

**Description:** To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G

**Measure:** Change from baseline in estimated glomerular filtration rate (eGFR)

**Time Frame:** 26 weeks

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria:

1. Male or female participants aged ≥18 years.
2. Urine protein \>0.75 g/24 hours or uPCR \>0.75 g/g.
3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
4. Participants receiving a RAAS inhibitor must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.
5. Participants receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitor or sparsentan must have been on a stable dose for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.
6. Kidney biopsy-proven diagnosis of IgAN, LN or C3G obtained within 26 weeks of Day 1.

Key Exclusion Criteria

1. A ≥50% decline in eGFR within 3 months before screening.
2. Concomitant significant renal disease other than IgAN, C3G, or LN.
3. Uncontrolled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive treatment.
4. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bharia@q32bio.com

**Name:** Bhavya Haria

**Phone:** 6173096647

**Role:** CONTACT

**Contact 2:**

**Email:** korr@q32bio.com

**Name:** Kristin Orr

**Phone:** 919.395.0132

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000005921

- Term: Glomerulonephritis

- ID: D000008180

- Term: Lupus Erythematosus, Systemic

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12338

- Name: Nephritis

- Relevance: HIGH

- As Found: Nephritis

- ID: M11178

- Name: Lupus Nephritis

- Relevance: HIGH

- As Found: Lupus Nephritis

- ID: M9032

- Name: Glomerulonephritis, IGA

- Relevance: HIGH

- As Found: IgA Nephropathy

- ID: M9031

- Name: Glomerulonephritis

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11177

- Name: Lupus Erythematosus, Systemic

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3523

- Name: Lupus Nephritis

- Relevance: HIGH

- As Found: Lupus Nephritis

- ID: T3008

- Name: IgA Nephropathy

- Relevance: HIGH

- As Found: IgA Nephropathy

- ID: T2525

- Name: Glomerulonephritis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009393

- Term: Nephritis

- ID: D000008181

- Term: Lupus Nephritis

- ID: D000005922

- Term: Glomerulonephritis, IGA

### Misc Info Module

- Version Holder: 2024-05-31
